Bioimaging and radiotherapy instruments

Various bioimaging and radiotherapy instruments

EMDN code Z1190

74 manufacturers, 324 models including 319 on the market, 20 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 74

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau	Germany	Advanced Markus chamber 0.02 cm³3 refs93/42 BeamAdjust93/42 BeamDose93/42 BEAMSCAN5 refs93/42 BEAMSCAN MR2 refs93/42 108 others BEAMSCAN Software93/42 Bragg Peak 1503 refs93/42 Bragg peak chamber 10.5 cm³3 refs93/42 CT ion chamber 3.14 cm³2 refs93/42 CT ion chamber 3.14 cm³, 100 mm long93/42 CT ion chamber, 300 mm long3 refs93/42 DETECTOR INTERFACE 400093/42 DiaCom93/42 DIAMENTOR C-RS2 refs93/42 DIAMENTOR chamber93/42 DIAMENTOR chamber KDK93/42 DIAMENTOR chamber KDK/GEMS N collimator93/42 DIAMENTOR chamber, circular, for CARD93/42 DIAMENTOR chamber, circular, not transparent93/42 DIAMENTOR chamber, for Toshiba Card93/42 DIAMENTOR chamber, size B93/42 DIAMENTOR CI-P93/42 DIAMENTOR CM-T93/42 DIAMENTOR K1S93/42 DIAMENTOR K2S93/42 DIAMENTOR M42 refs93/42 DIAMENTOR M4-KDK2 refs93/42 DIAMENTOR RS-KDK2 refs93/42 Dosimetry Cables3 refs epidSoft93/42 Farmer chamber 0.6 cm³, C/Al3 refs93/42 Farmer chamber 0.6 cm³, PMMA/Al3 refs93/42 Farmer chamber 0.6 cm³, water-proof93/42 Farmer chamber 0.6 cm³, waterproof2 refs93/42 HDR chamber 200 cm³93/42 Inclinometer wireless93/42 IsoCheck93/42 IsoCheck epid93/42 Manual Water Phantoms6 refs Marcus chamber 0.055 cm³3 refs93/42 Mechanical Tools T20020.1.1003 refs Mechanical Tools T20020.1.2003 refs microDiamond3 refs93/42 microSilicon3 refs93/42 microSiliconX3 refs93/42 MP1 acrylic water tank93/42 MP1 acrylic water tank, extra lines93/42 MP1-S acrylic water tank93/42 MP1Control93/42 MP3-P acrylic tank with moving mechanism93/42 MP3-P45 acrylic tank w/ moving93/42 MP3-PL acrylic tank with moving mechanism93/42 MP3-T acrylic tank93/42 MP3-XS93/42 MP3-XS water phantom ZAP93/42 MultiCheck93/42 NOMEX Dosemeter93/42 NOMEX MAM detector93/42 NOMEX mAs93/42 NOMEX Multimeter93/42 NOMEX R/F/D detector93/42 NOMEX Software93/42 OCTAVIUS 4D MR chamber plate Semiflex 3D OCTAVIUS Phantoms3 refs OCTAVIUS Control Unit93/42 OCTAVIUS Detector 1000 SRS93/42 OCTAVIUS Detector 150093/42 OCTAVIUS Detector 1500 MR93/42 OCTAVIUS Detector 1500 XDR93/42 OCTAVIUS Detector 1600 MR93/42 OCTAVIUS Detector 1600 SRS93/42 OCTAVIUS Detector 1600 XDR93/42 OCTAVIUS Rotation Unit Modular93/42 PinPoint 3D chamber 0.016 cm³3 refs93/42 PinPoint 3D MR chamber 0.016 cm³3 refs93/42 PinPoint chamber 0.015 cm³2 refs93/42 PinPoint chamber 0.03 cm³3 refs93/42 PinPoint-Kammer 0,015 cm³93/42 PQASoft93/42 QUICKCHECK2 refs93/42 Roos chamber 0.35 cm³3 refs93/42 RUBY head phantom Radiotherapy Phantoms/Test Objects3 refs SCANLIFT carriage and reservoir93/42 Semiflex 3D chamber 0.07 cm³3 refs93/42 Semiflex 3D MR chamber 0.07 cm³3 refs93/42 Semiflex chamber 0.125 cm³3 refs93/42 Semiflex chamber 0.3 cm³3 refs93/42 SFD diagnostic chamber 75 cm³3 refs93/42 SFD MAM chamber, 6 cm³93/42 SFD mammo chamber 6 cm³3 refs93/42 Soft X-ray chamber 0.005 cm³15 refs93/42 Soft X-ray chamber 0.02 cm³9 refs93/42 SOURCECHECK 4PI3 refs93/42 STARCHECK93/42 STARCHECK maxi93/42 STARCHECK maxi MR93/42 T-REF chamber 10.5 cm³3 refs93/42 TANDEM3 refs93/42 TANDEM XDR3 refs93/42 TanSoft93/42 TBA control pendant93/42 TBA control unit93/42 Thin-window Bragg peak chamber 10.5 cm³3 refs93/42 Track-it93/42 UNICHECK UNICHECK Beam Constancy Check v1 UNIDOS E3 refs93/42 UNIDOS Romeo3 refs UNIDOS webline3 refs93/42 UniSoft Edition 200093/42 VERIQA93/42 VERIQA RT EPID 3D v32 refs VeriSoft93/42 Farmer chamber 0.6 cm³, C/C3 refs93/42 (no longer marketed)	I, IIb MDR, 93/42	Website info@ptwdosimetry.com EUDAMED record Report an error
IBA Dosimetry FDA	Germany	Blue Phantom Compact Blue Phantom Helix Blue Phantom PT Blue Phantom² CC04 Ion chamber3 refs 33 others DOSE-X (BNC)2 refs Dosimax plus3 refs Gantry Sensor+ Giraffe with OmniPro Incline93/42 KermaX-plus 102-126 TINO3 refs MatriXX One93/42 MatriXX Resolution minPhantom R myQA Accept myQA Blue Phantom³ myQA Daily myQA FastTrack2 refs myQA FastTrack PT myQA iON myQA MatriXX Air myQA Patients myQA Phoenix myQA QuickLevel myQA SRS Detector2 refs myQA SRS Phantom Cyberknife Edition2 refs myQA StarTrack3 myQA StarTrack3 Web-Based Application Phoenix Nozzle Holder for Proteus+3 refs SMfit Sphinx Compact Sphinx SF2 refs StarTrack93/42 Stealth Chamber3 refs Stingray3 refs Universal I'mRT Phantom WP1D3 refs WP34 Zebra with OmniPro Incline93/42	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Foreseeson Custom Displays FDA EU representative : KTR Europe GmbH (Germany)	United States	4K Color Display FM-A5504DG, FM-A5504DS 4K Color Display FM-E2701D, FM-E2701DG 4K Color Display FM-E2701DT, FM-E2701DGT 4K Color Display FM-E3203D, FM-E3203DC, FM-E3203DG 4K Color Display FM-E3230D, FM-E3230DG, FM-E3230DN 28 others 4K Color Display FM-F2701D 4K Color Display FM-F2701DG 4K Color Display FM-F3101D 4K Color Display FM-F3101DG 4K UHD Monitor FM-A5503DC 4K UHD Monitor FM-A5505DGC 4K UHD Monitor FM-D5802DV 4K UHD Monitor FM-E3204DGC Image Processing System IPS710A Image Processing System IPS720 Image Processing System IPS740DG, IPS740DS LCD Color Display FM-A2701D, FM-A2701DS LCD Color Display FM-B2702D, FM-B2702DG LCD Color Display FM-C5501DV LCD Color Display FM-D5801DV LCD Color Display FS-A2702DS, FS-A2702DT LCD Color Display FS-A3202DS LCD Color Display FS-E2101D, FS-E2101DT LCD Color Display FS-E2102D, FS-E2102DT LCD Color Display FS-L2403D LCD Color Display FS-L2702D, FS-L2702DT LCD Color Display FS-L3202D LCD Color Display FS-P2404D LCD Color Display FS-P2603D LCD Color Display FS-P2604D LCD Color Display FS-P3102D, FS-P3102DG, FS-P3102DS LCD Color Display FS-Y1901D OLED 4k Color Display FM-A5502DC	I MDR	Website EUDAMED record Report an error
Jvckenwood FDA EU representative : JVCKENWOOD Deutschland GmbH (Germany)	Japan	CL-E270WA0EA 27-inch (68.6 cm) Color LCD Monitor CL-R190BN0EA 19.0-inch (48 cm) Color LCD Monitor CL-R211BN0EA 21.3-inch (54 cm) Color LCD Monitor CL-R813BN0EA 32-inch (81. 3cm) Color LCD Monitor CL-S1200BGEA 30.9-inch (78.4 cm) Color LCD Monitor 11 others CL-S200BF0EA 21.3-inch (54 cm) Color LCD Monitor CL-S300BF0EA 21.3-inch (54 cm) Color LCD Monitor CL-S301BA0EA 21.3-inch (54 cm) Color LCD Monitor CL-S500BG0EA 21.3-inch (54 cm) Color LCD Monitor2 refs CL-S600BA0EA 30.0-inch (76.2 cm) Color LCD Monitor CL19196-J01E 19-inch (48 cm) Color LCD ML19001-B0S1 19-inch (48 cm) Monochrome LCD ML19195-J00E 19-inch (48 cm) Monochrome LCD MS-S200BF0EA 21.3-inch (54 cm) Monochrome LCD Monitor MS-S300BF0EA 21.3-inch (54 cm) Monochrome LCD Monitor MS-S500BG0EA 21.3-inch (54 cm) Monochrome LCD Monitor2 refs	I MDR	Website EUDAMED record Report an error
Optomed FDA	Finland	Optomed Aurora4 refs93/42 Optomed Aurora camera93/42 Optomed Smartscope4 refs93/42 Signal Camera93/42 Smartscope93/42 1 other Visuscout 10093/42	I, IIa 93/42	Website regulatory@optomed.com EUDAMED record Report an error
Barco FDA EU representative : Barco NV (Belgium)	Belgium, China, Italy, United States	Barco Clinical Review Display6 refs Barco Radiology Display9 refs Barco Surgical display6 refs Barco surgical monitor6 refs Coronis Uniti Radiology Display2 refs	I, IIa MDR	Website EUDAMED record Report an error
EIZO FDA EU representative : EIZO GmbH (Germany)	Germany, Japan	CuratOR EX2620-3D-WT3 refs CuratOR LL550W3 refs CuratOR MIR-13 refs RadiForce GX240-CL-BK3 refs RadiForce GX570A-ARBK3 refs	I, IIa MDR	Website EUDAMED record Report an error
Lge FDA EU representative : LG Electronics Deutchland GmbH (Germany)	South Korea	21HK512D3 refs 21HQ513D3 refs 21HQ613D6 refs 24CR670N3 refs 27HJ710S3 refs	I, IIa MDR	eudamed-lge@lge.com EUDAMED record Report an error
OsteoSys EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	BeeTLe DEXXUM T3 refs EXCELLUS2 refs iNSiGHT C410 iNSiGHT C5102 refs SONOST-2000 SONOST-30002 refs	IIa, IIb MDR	Website EUDAMED record Report an error
A.T.S. Applicazione Tecnologie Speciali FDA	Italy	HIRIS RF43-FL93/42 HIRIS RF43-TS93/42 PRIMAX INTERNATIONAL HIRIS RF43-TS93/42 VSM DRF 4343-TS93/42	IIb 93/42	Website quality@atsmed.it EUDAMED record Report an error
Eurotec Medical Systems	Italy	DENSITY Density NFB Density PB Density S-NFB	IIb MDR	Website info@eurotec-ms.com EUDAMED record Report an error
Ge Medical Systems Ultrasound Primary Care Diagnostics FDA EU representative : GE Medical Systems SCS (France)	United States	Compact93/42 Full H8930CA93/42 Lunar Astra2 refs Lunar iDXA93/42	IIb MDR, 93/42	eudamed@gehealthcare.com EUDAMED record Report an error
Bildteknik	Sweden	FluoroStore FS001 InVision PharyDoc PD001	I MDR	Website info@bildteknik.com EUDAMED record Report an error
Cizgi	Türkiye	GP-424 VI Operating Room Computer Console and Video Integration Software GP-446 VI Operating Room Computer Console and Video Integration Software GP-449 VI Operating Room Computer Console and Video Integration Software	I MDR	Website info@cizgi.net EUDAMED record Report an error
ECRA	Italy	MEDICAL PANEL PC4 refs MONITOR MEDICALE7 refs TABLET MEDICALE2 refs	I MDR	EUDAMED record Report an error
TherMidas FDA	Finland	TherMidas IR System ThIR-A61593/42 Thermidas IRT-384 Tablet ThIR-384 TherMidas Remote ThRemote93/42	I, IIa MDR, 93/42	Website EUDAMED record Report an error
C-RAD Positioning FDA	Sweden	Catalyst+ PT2 refs HIT13 refs Catalyst+93/42 (no longer marketed) Catalyst+ HD93/42 (no longer marketed) Catalyst+ HD Ring Gantry93/42 (no longer marketed) 1 other Sentinel 4DCT93/42 (no longer marketed)	I, IIb MDR, 93/42	Website info@c-rad.com EUDAMED record Report an error
EUSA Global FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	ENDODIGI EN1024 ENDODIGI HD U1EN105/2	I MDR	Website EUDAMED record Report an error
Hikimaging EU representative : SUNGO Europe B.V. (Netherlands)	China	Glimessen GET-DA770-HA5/5G Glimessen GET-DA770-HA5/5GAI	I MDR	Website EUDAMED record Report an error
Italray	Italy	X-FRAME DR EZ5 refs X-FRAME DRF SRD+IR700-A	IIb MDR	Website info@italray.it EUDAMED record Report an error
medical ECONET	Germany	Inus D93/42 Inus S93/42	IIa, IIb 93/42	Website info@medical-econet.com EUDAMED record Report an error
MediCapture FDA EU representative : MEDICAPTURE EUROPE B.V. (Netherlands)	United States	MTS1013 refs MVR3 refs	I MDR	Website info@medicapture.com EUDAMED record Report an error
Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	Intraoral Scanner SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, TRIOS-113 refs Photogrammetry Camera iMapper	I MDR	ra01@runyes.com EUDAMED record Report an error
Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇	Türkiye	Hareketli Lazer93/42 Sabit Lazer93/42	I 93/42	Website info@radonfix.net EUDAMED record Report an error
Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iGrapher IOS-11, 3DS Mega, 3DS Ultra, SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, ORAL-O3, SCAN-O5, SCAN-O63 refs	I MDR	EUDAMED record Report an error
Shenzhen KTC Medical Solutions EU representative : SUNGO Europe B.V. (Netherlands)	China	32A30-L02 refs Diagnostic Monitor 21X3C-I32 refs	I MDR	EUDAMED record Report an error
Shenzhen Yuanzhuo Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	YE270F，YE270FM，YE270U,YE270Q,YE****,YX**,Y****( can represent 0-9,A-Z,a-z,+,-,\,/ or empty numbers,representing different appearance color(shell material is the same) etc3 refs YE320UP，YE320U，YE320UM,YE320UMP,YX315U,YE****,YX**,Y****( can represent 0-9,A-Z,a-z,+,-,\,/ or empty numbers,representing different appearance color(shell material is the same) etc3 refs	I MDR	EUDAMED record Report an error
Stratec Medizintechnik FDA	Germany	XCT 200093/42 XCT 300093/42	IIb 93/42	info@stratec-med.com EUDAMED record Report an error
Apelem FDA	France	FDX Visionary-A (compact version) STRATOS3 refs	IIb MDR	regulatory@dms-imaging.com EUDAMED record Report an error
ARANZ Medical EU representative : mdi Europa GmbH (Germany)	New Zealand	Silhouette	I MDR	Website quality@aranzmedical.com EUDAMED record Report an error
BeamMed FDA EU representative : AR Experts B.V. (Netherlands)	Israel	MiniOmni93/42	IIa 93/42	Website EUDAMED record Report an error
Beijing ShiYan Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	3D LCD Monitor S320-1M	I MDR	service@shiyan-tech.com EUDAMED record Report an error
BLTY (Hangzhou) Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	universal OR102 refs	I MDR	EUDAMED record Report an error
Body Vision Medical FDA EU representative : AR Experts B.V. (Netherlands)	Israel	LungVision CORE2 refs	IIa MDR	Website EUDAMED record Report an error
Brainlab FDA	Germany	Wall Touch Screen	I MDR	regulatory.affairs@brainlab.com EUDAMED record Report an error
Dotincorp EU representative : Grambly GmbH (Germany)	South Korea	Dot Pad DPA320A2 refs	I MDR	Website inquiry@dotincorp.com EUDAMED record Report an error
Endoso FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	M-32W、M-32B、M-32C3 refs	I MDR	EUDAMED record Report an error
Erbe Vision FDA	Germany	Medical monitor 21" HD3 refs	I MDR	Website info.vision.de@erbegroup.com EUDAMED record Report an error
Foshan Duoyimei Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	SKI-102,SKI-103,SKI-105,SKI-106	I MDR	EUDAMED record Report an error
Guangzhou Shichuang Display Technology EU representative : Share info GmbH (Germany)	China	Shichuang E328V3 refs	I MDR	EUDAMED record Report an error
Incremed FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Switzerland	SonoEyes R2.0	I MDR	Website support@incremed.com EUDAMED record Report an error
JENSHI Digital Technology (Nanjing) EU representative : GRZAN GROUP SL (Spain)	China	CloudCapture 4K	I MDR	EUDAMED record Report an error
Jusha FDA EU representative : Lotus NL B.V. (Netherlands)	China	LCD Monitor3 refs	I MDR	Website ra@jusha.com.cn EUDAMED record Report an error
Klarity Medical & Equipment（GZ） EU representative : Lotus NL B.V. (Netherlands)	China	Many3 refs	I MDR	sales@klarity-medical.com EUDAMED record Report an error
Lap Laser Applikationen FDA	Germany	APOLLO MR3T blue cross-hair3 refs	I MDR	Website info@lap-laser.com EUDAMED record Report an error
Linden Group FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	Optik View SC Series Surgical LCD Monitor3 refs	I MDR	Website support@tlgc.com EUDAMED record Report an error
Medical Ip FDA EU representative : Advena Limited (Malta)	South Korea	MEDIPPRO93/42	IIa 93/42	Website EUDAMED record Report an error
MedicalTek FDA EU representative : KOMAS Medical Technology GmbH (Germany)	Taiwan	Lascaux Medical Recorder	I MDR	info@mdtk.com.tw EUDAMED record Report an error
Medikors EU representative : Javitech Consulting GmbH (Germany)	South Korea	InAlyzer AIR93/42	IIb 93/42	Website EUDAMED record Report an error
Milton Essex	Poland	SkinSensic głowica dermatoskopowa do nieinwazyjnego obrazowania zmian skórnych alergicznych SS024-IRVIS	I MDR	Website EUDAMED record Report an error
Mimsal	Spain	AF 200 d/c LED3 refs	I MDR	regulatory@mimsal.com EUDAMED record Report an error
Ningbo Rundeer Control Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	SCAN33	I MDR	ra02@runyes.com EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany)	Japan	4K UHD LCD MONITOR OEV321UH	I MDR	EUDAMED record Report an error
PENTAX of America FDA EU representative : PENTAX Europe GmbH (Germany)	United States	Digital Capture 9380	I MDR	EUDAMED record Report an error
Proma Medikal Şti	Türkiye	SCHRODER - NT 110 - NEGATOSCOPE, SINGLE3 refs	I MDR	Website EUDAMED record Report an error
Shenyang Torch-BigTide Digital Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	LCD Monitor3 refs	I MDR	EUDAMED record Report an error
Shenzhen Beacon Display Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	BEACON S3281P3 refs	I MDR	EUDAMED record Report an error
Shenzhen Bigtide Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	M(C/G)20/30/50A, MC40/60/80(A/B), MD4270/8550/8650(F/TF), MS2150/2151/2210/2238/2240/8238/8270/8275/4270/2270/ 8272/8276/8278/8320/8321/8550(A/P/T), MS8275(A-001,P-001,T-001), MS8270/8320/8321/8550(A-S1/P-S1/T-S1/A-S2/P-S2/T-S2)3 refs	I MDR	EUDAMED record Report an error
Shenzhen JLD Display Expert EU representative : MedPath GmbH (Germany)	China	LCD Monitor31 refs	I MDR	EUDAMED record Report an error
Shenzhen WeSee Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Medical LCD Monitor FHD,UHD,QUHD,3M,QHD.3 refs	I MDR	EUDAMED record Report an error
Shenzhen Yuezhongxing Technology FDA EU representative : Kingsmead Service B.V. (Netherlands)	China	Endoscope Image Processor vCent-300	IIa MDR	EUDAMED record Report an error
TEAC FDA EU representative : TEAC Europe GmbH (Germany)	Japan	UR-4MD UR-NEXT4K3 refs	I MDR	Website EUDAMED record Report an error
Tedisel	Spain	DIAMOND L3 refs	I MDR	Website info@tedisel.com EUDAMED record Report an error
Tianjin Youshidacheng Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	YSD-660，YSD-880A，YSD-880C，YSD-880RT，YSD-960，YSD-960RT，YSD-960PT，YSD-960SC，YSD-880AW，YSD-880CW，YSD-980，YSD-980PT，YSD-6S，YSD-8S，YSD-9S，YSD-9RT，YSD-8W3，YSD-9W3，YSD-9W，YSD-880AM，YSD-880CM，YSD-960M，etc	I MDR	EUDAMED record Report an error
Timpel FDA EU representative : MDSS GmbH (Germany)	Brazil	ENLIGHT 21003 refs	IIa MDR	EUDAMED record Report an error
TRUEinvivo EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	DOSEmapper 1D3 refs	I MDR	Website info@trueinvivo.co.uk EUDAMED record Report an error
V.I.M.S Video Interventionnelle Medicale Scientifique	France	Monitor for coverable videoscopic system3 refs	I MDR	contact.vims@zimmerbiomet.com EUDAMED record Report an error
Veirun FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Intraoral Scanner DK-100	I MDR	info@veirun.com EUDAMED record Report an error
Verathon FDA EU representative : Verathon Medical (Europe) B. V. (Netherlands)	Canada	GlideScope Core 103 refs	I MDR	Website Regulatory.Compliance@verathon.com EUDAMED record Report an error
Xenosys FDA EU representative : S.B. Pharma GmbH (Germany)	South Korea	LooksCAM22 refs	I MDR	qa@xenosys.co.kr EUDAMED record Report an error
Xi'An Visbody Intelligent Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Visbody 3D Posture & Alignment Tracking and Assessment System Visbody-S20, S30, S40, S50, S60, Visbody-R Explorer, Visbody-M30, M50, M60, M90, T55, T58, D Pro3, R10, R30, R60, R70, R80, R90, T50, T303 refs	I MDR	EUDAMED record Report an error
Xuzhou Akx Electronic Science Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	YKD-8019；YKD-8022；YKD-8024；YKD-8027；YKD-8032；YKD-8127；YKD-8132；YKD-81553 refs	I MDR	EUDAMED record Report an error
Zhenhealth EU representative : MedPath GmbH (Germany)	China	Fundus camera	I MDR	EUDAMED record Report an error
Zhuhai Aicreate Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	A3M，A3M-X，A3S，A3S-X，A3W，A3W-X， A6M, A6M-X, A6S，A6S-X，A6W-X，A6W， A9M，A9M-X，A9S，A9S-X，A9W， A9W-X	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 428

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
BIOMET MICROFIXATION, INC Present in Europe in other categories	United States	–	registered
KLS-Martin L.P. Present in Europe in other categories	Germany	IPS	K182789 (2019)
Nds Surgical Imaging	United States	RADIANCE EndoVue 4Klear LifeVue Evolution4K HDMD PRO	registered
Medcad	United States	AccuPlan System AccuModel AccuPlan® System AccuModel®	K223024 (2023)
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL Present in Europe in other categories	United States	Accu-Beam	registered
Modus Medical Devices Inc	Canada	QUASAR Vista ClearView QUASAR Static Phantom IBA QUASAR™ Programmable Respiratory Motion Phantom 2	registered
3D Systems, Inc.	United States	VSP System VSP System, VSP Cranial	K261826 (2026)
Canon Medical Informatics, Inc. Present in Europe in other categories	United States	Vitrea Read EasyViz Vitrea Advanced Visualization Vitrea View	registered
Sun Nuclear Corp. Present in Europe in other categories	United States	CT Sim+ Sun Nuclear MICRO+ MR Sun Nuclear MICRO Sun Nuclear MICRO+ Sun Nuclear BR12 Breast REFERENCE DETECTOR (TNC)	registered
Brit Systems, LLC	United States	Roentgen Works Roentgen Files	K943383 (1994)
Providus Holdings, Inc.	–	Catphan® ECTphan™ Magphan® Corgi® Low Contrast MITA Head Phantom Low Contrast MITA Body Phantom	registered
Synthes GmbH Present in Europe in other categories	United States	MatrixMANDIBLE Matrix MatrixMIDFACE	registered
Guangdong Meicen Medical Equipment Co., Ltd. Present in Europe in other categories	China	Meicen	registered
Conmed Corporation Present in Europe in other categories	United States	CONMED ENTREE TRINITY TOUCH GLASS	registered
SONY CORPORATION	Japan	SONY	K890826 (1989)
STANDARD IMAGING INC. Present in Europe in other categories	United States	Standard Imaging Exradin A12SMR Ion Chamber Standard Imaging Exradin A1SL Ion Chamber Standard Imaging Exradin A14 Ion Chamber Standard Imaging CDX 2000B Electrometer Standard Imaging Exradin A16 Ion Chamber Standard Imaging Exradin Magna 600	K042733 (2004)
AADCO MEDICAL, INC.	United States	Hercules AADCO MRI-Safe Rayshield	registered
Icad, Inc.	United States	PowerLook PRO+ 4GPU Tower Platform, OUS PowerLook PRO+ Rack-Mount, OUS PowerLook PRO+ 4GPU Tower Platform, US ProFound AI 3.1 PowerLook PRO+ Rack-Mount, US PowerLook Cloud 1.0	registered
TIDI PRODUCTS, LLC	United States	TIDISHIELD TIDI Air Techniques Sirona Kavowerk Dentale Einrichtungen Sopro	registered
Micro-Tech (Nanjing) Co., Ltd.	China	Single-use Video Scope eyeMAX(TM) Single-use Video Pancreaticobiliary Scope	registered
Joimax GmbH Present in Europe in other categories	Germany	Flatscreen Monitor trolley Vitegra® microphone	registered
Stryker Leibinger GmbH & Co. KG Present in Europe in other categories	Germany	DELTA	registered
ILO electronic GmbH Present in Europe in other categories	Germany	ILO	registered
Carestream Health, Inc. Present in Europe in other categories	United States	CS 7600 Hygienic Sheath Hygienic Sleeves 3D Bite Block Hygienic Sleeves Ear Cones Hygienic Sleeves Bite Block Hygienic Sheaths DRX - Ascend System	registered
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	–	C-Arm Cover 152/265 C-Arm Cover IMAGE INTENSHFIER 115/240 Protective Cover 90/90cm Image Cover 45R Protective Cover 80/100cm Protective Cover 75/90cm	registered
Dongguan Teac Electronics Co., Ltd.	–	UR-4MD MDR-600HD	registered
Smith & Nephew, Inc. Present in Europe in other categories	United States	RADIANCE BARCO 660HD-E Image Management System Kit Portuguese 660HD-E IMS KIT Danish 660HD-E IMS	registered
Gyrus Acmi, Inc. Present in Europe in other categories	United States	nCare Olympus	registered
Good Doctors Co., Ltd. Present in Europe in other categories	South Korea	Whicam Story3_wired Dr's Cam_wireless Disposable cover_46x195_wide/100 pcs EZ SHOT HD V Whicam Story3_wireless Dr's Cam_touch	registered
BR Surgical, LLC	–	BR Surgical, LLC	registered
Avreo, Inc.	United States	interWORKS	registered
BLACK DIAMOND VIDEO, INC.	United States	Vividimage 4K HexaVue Vividimage W Vividimage D HD Vividimage W 4K	registered
FIMI SRL	–	Barco	registered
IMAGE DIAGNOSTICS, INC.	United States	IMAGE DIAGNOSTICS, INC IMAGE DIAGNOSTICS INC IMAGE DIAGNOSTICS, INC.	registered
CARESTREAM DENTAL LLC Present in Europe in other categories	United States	CS 7600 Hygienic Sheath Hygienic Sheath Hygienic Sleeves Ear Cones SINGLE USE SLEEVES - PANO BITE BLOCK SINGLE USE SLEEVES - EAR RODS SINGLE USE SLEEVES - 3D BITE BLOCK	registered
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung	–	ImageCam 3 (Adapt.: Topcon SL-2E) ImageCam 3 (Adapt.: Zeiss SL120) ImageCam 3 (Adapt.: RO 4000/5000) ImageCam 3 (Adapt.: Nikon) ImageCam 3 (Adapt.: Haag-Streit BQ-900) ImageCam 3(Adapt.: Leica)	registered
Storage Solutions Technology Group Inc.	–	DMC-EZ	registered
TEAC MANUFACTURING SOLUTIONS CORPORATION	–	UR-NEXT4KH UR-NEXT4KS UR-X UR-4MD	registered
IMRIS Imaging, Inc. Present in Europe in other categories	United States	IMRISmatrix 5.0 VISIUSmatrix	registered
Mindways Software, Inc. Present in Europe in other categories	United States	QCT PRO Asynchronous 3D Spine and CTXA-Hip System QCT PRO Asynchronous 3D Spine Software QCT PRO 3D Volumetric Spine and CTXA Hip Software QCT PRO 3D Volumetric Spine Software CTXA Hip Extended Reference Data QCT PRO 3D Volumetric Spine System	K140342 (2014)
Aktina Corp. Present in Europe in other categories	–	Cross-Hair Reticule, Open-Air Cross-Hair Reticule, Radiation Opaque Port Film Graticule, Siemens Compatible Cross-Hair Reticule, XRETIC Port Film Graticule, Tray Mount, Elekta Compatible Port Film Graticule, Latch Mount, Elekta Compatible	registered
Baxter Medical Systems GmbH + Co. KG Present in Europe in other categories	–	VidiaPort TV HD Pre-Install Set TV HD Wireless Sterilizable Handles 4K Camera	registered
Codonics, Inc. Present in Europe in other categories	United States	Codonics Virtua® C Controller - 91C Codonics Virtua® C Controller - 90C Codonics Virtua® C/E Medical Disc Publisher Codonics Virtua® Controller - 73C Codonics Virtua® XR Medical Disc Publisher Codonics Virtua® XR Controller - 76C	registered
Dentall co.,Ltd. Present in Europe in other categories	United States	EzCam Camstar Opti plus HD LED IC100 IOC-Holder IOC-USB Cable	registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories	United States	Aspen® O.R. Camera Cover Adapter Aspen® O.R. Camera Cover	registered
FUSION ORTHOPEDICS, LLC	United States	PolyLock Midfoot FuzeFix Chamfered Screws PolyLock FuzeFix Max FT	registered
Hologic, Inc. Present in Europe in other categories	United States	Horizon C Horizon W Horizon Wi Horizon A Horizon Ci Cenova	K130277 (2013)
Durico C&T Inc. Present in Europe in other categories	South Korea	SUPER ULSTAR	registered
SKYTRON LLC	United States	TV-3 Camera Control Unit with RS232 Connection Precision HD Camera for Lumos TV-3 Handle Camera, Aurora II Series TV-3 Handle Camera Aurora 3 and Four Series Camera SkyVision	registered
Wide Corporation	South Korea	CX30N MX30N MX50T CW60N CW120N CL24N	K222719 (2023)
MAQUET GmbH Present in Europe in other categories	Germany	Maquet Orchide	registered
MeVis Medical Solutions AG Present in Europe in other categories	United States	MammoScape Veolity Visia LungCAD DynaCAD Lung Server Veolity LungCAD DynaCAD Lung	K201501 (2021)
UNIRAY MEDICAL LLP	India	UniRay	registered
Aidoc Medical , Ltd. Present in Europe in other categories	Israel	aiOS BriefCase Triage	K243548 (2024)
HARRISON-AI MEDICAL PTY LTD Present in Europe in other categories	Australia	Annalise Triage Annalise Enterprise Annalise Critical Care AI	registered
Medimaps Group SA Present in Europe in other categories	Switzerland	TBS iNsight Phantom CORELab	K243218 (2025)
Qingdao Hisense Medical Equipment Co., Ltd.	China	Hisense	K222208 (2022)
ARTHREX, INC. Present in Europe in other categories	United States	Arthrex®	registered
Cardinal Health 200, LLC Present in Europe in other categories	United States	CARDINAL HEALTH	registered
HUESTIS MACHINE CORPORATION	United States	Huestis Centralite Patient Positioning Laser	registered
HYLAND LLC	–	PACS Scan Mobile Media Writer PACSgear PACS Scan Web PACSgear Media Writer Web Media Writer CD	registered
Novocam Medical Innovations Oy Present in Europe in other categories	Finland	futudent	registered
Radius	United States	ViewBox Advanced ViewBox Basic PACSCore ConnectWeb with PACSCore DicomForward Vendor Neutral Archive with ConnectWeb	registered
3D LIFEPRINTS UK LTD	United Kingdom	EmbedMed	K220366 (2022)
CLIKTECH LLC	United States	ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX ClikRay Size 2 Sensor Cover 40mm/ Box 500 ClikRay Green Line Universal Large Sensor Cover 40mm/500Box ClikRay Size 1 Sensor Cover 34mm/ 500 box ClikRay Size 1+2 Sensor Cover 36mm/ Box 500	registered
FENTEX medical GmbH Present in Europe in other categories	Germany	FENTEX	registered
STRYKER CORPORATION Present in Europe in other categories	United States	TPX	K943540 (1994)
ADLINK Technology GmbH	Germany	–	registered
Aesculap, Inc. Present in Europe in other categories	United States	AESCULAP	registered
Carl Zeiss Meditec, AG Present in Europe in other categories	United States	ZEISS CONNECT CALLISTO eye Panel PC INTRABEAM® Water Phantom	registered
Cv Medical, LLC	–	DOCS NuBOOM NuVEIW NuCART	registered
DEXIS LLC	United States	DEXcam4™ Intra-oral camera sheaths DEXcam3™ intra-oral camera sheaths	registered
GE Medical Systems Present in Europe in other categories	United States	Quality Care Suite Critical Care Suite	K183182 (2019)
Get-Grin Inc.	United States	Grin Website Grin App Grin Records App Grin App -W	registered
Medscint Inc.	Canada	HYPERSCINT QA	registered
NZ Technologies Inc	–	NZ Technologies Inc	registered
Rocoto Inc.	Israel	Rocoto Amimon	registered
ASUSTEK COMPUTER INCORPORATION	–	ASUS	registered
BGSS Company Inc.	–	SAFE DENT	registered
Boston Scientific Corp Present in Europe in other categories	United States	SpyGlass DS	registered
Elekta Solutions AB Present in Europe in other categories	Sweden	AQUA	registered
Ischemaview, Inc. Present in Europe in other categories	United States	Rapid	K230074 (2023)
LONG ISLAND TECH	–	Pharos HD CCU Pharos HD System Pharos HD Headcam	registered
Lunit, Inc. Present in Europe in other categories	South Korea	Volpara Live Lunit INSIGHT CXR Triage	K211733 (2021)
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
MedCom Gesellschaft für medizinische Bildverarbeitung mbH Present in Europe in other categories	–	Prelude	registered
Medtec, Inc. Present in Europe in other categories	United States	CT Simulation Laser QA Device Iso-Align™ Iso-Point	registered
NANO-X AI LTD Present in Europe in other categories	Israel	HealthPNX HealthPPT HealthMammo	registered
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.	United States	ENDOPRO-CAM Master Series AED ENDOPRO® PRIMO SERIES CAMERA AED ENDOPRO-CAM®	registered
Propel Orthodontics, LLC	United States	Propel	K172164 (2018)
STERIS Corporation Present in Europe in other categories	United States	HarmonyAIR	registered
STRYKER COMMUNICATIONS INC. Present in Europe in other categories	United States	StrykeCam In-Light Camera	registered
Sentiar, Inc.	United States	SentiAR	registered
Varian Medical Systems, Inc. Present in Europe in other categories	United States	MaximQA Varian FractionLab Varian DoseLab TG-142	registered
3D-Shaper Medical S.L Present in Europe in other categories	Spain	3D-SHAPER	K251022 (2025)
AMIMON LTD	–	Amimon	registered
Acula Technology Corp.	Taiwan	LUMIN	K241499 (2024)
CAMBER SPINE TECHNOLOGIES, LLC	United States	VARIANT	registered
Claripi, Inc. Present in Europe in other categories	South Korea	ClariPlatform	registered
Coreline Soft Co., Ltd. Present in Europe in other categories	South Korea	AVIEW Lung Nodule CAD	K251203 (2025)

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