Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsRadiology instruments

Radiology instruments - other

EMDN code Z11030599

11 manufacturers, 133 models including 133 on the market, 9 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 11

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
Varex Imaging FDA EU representative : Arazy Group GmbH (Germany)	Germany, Netherlands, United States	AMPMC 100193/42 Digital Image Receptors - Portable Digital Image Receptors -Stationary Varex Imaging6 refs Varex Imaging AMPMC 100293/42 84 others Varex Imaging AMPMC 100693/42 Varex Imaging AMPMC 1006, CONFIG 0193/42 Varex Imaging AMPMC 100793/42 Varex Imaging AMPMC 100893/42 Varex Imaging AMPMC 101293/42 Varex Imaging ICX1101B93/42 Varex Imaging ICX1113B93/42 Varex Imaging ICX1121B93/42 Varex Imaging ICX1140B93/42 Varex Imaging ICX1141B93/42 Varex Imaging ICX1153B93/42 Varex Imaging ICX1159B93/42 Varex Imaging ICX1162B93/42 Varex Imaging ICX1192B93/42 Varex Imaging ICX1217B93/42 Varex Imaging ICX1219B93/42 Varex Imaging ICX122B93/42 Varex Imaging ICX127B93/42 Varex Imaging ICX136B93/42 Varex Imaging ICX140B93/42 Varex Imaging ICX141B93/42 Varex Imaging ICX142B93/42 Varex Imaging ICX143B93/42 Varex Imaging ICX145B93/42 Varex Imaging ICX146B93/42 Varex Imaging ICX155B93/42 Varex Imaging ICX1562B93/42 Varex Imaging ICX1759B93/42 Varex Imaging ICX1940B93/42 Varex Imaging ICX1945B93/42 Varex Imaging ICX1946B93/42 Varex Imaging ICX1977B93/42 Varex Imaging ICX1994B93/42 Varex Imaging ICX1996B93/42 Varex Imaging ICX1997B93/42 Varex Imaging ICX1998B93/42 Varex Imaging ICX2122B93/42 Varex Imaging ICX222B93/42 Varex Imaging ICX237B93/42 Varex Imaging ICX251B93/42 Varex Imaging ICX2941LB93/42 Varex Imaging ICX2941RB93/42 Varex Imaging ICX297B93/42 Varex Imaging ICX3122B93/42 Varex Imaging ICX322B93/42 Varex Imaging ICX3722B93/42 Varex Imaging ICX3922B93/42 Varex Imaging ICX3954B93/42 Varex Imaging ICX4122B93/42 Varex Imaging ICX555B93/42 Varex Imaging ICX722B93/42 Varex Imaging ICX914B93/42 Varex Imaging ICX937B93/42 Varex Imaging ICX945B93/42 Varex Imaging ICX949B93/42 Varex Imaging ICX954B93/42 Varex Imaging ICX967B93/42 Varex Imaging ICX970B93/42 Varex Imaging ICX975B93/42 Varex Imaging ICX986B93/42 Varex Imaging ICX989B93/42 Varex Imaging ICX995B93/42 Varex Imaging ICX996B93/42 Varex Imaging ICX997B93/42 Varex Imaging ICX999B93/42 Varex Imaging INX147B93/42 Varex Imaging INX247B93/42 Varex Imaging SolidStateMC set 501, 100193/42 Varex Imaging SSMC SET 501, 1001, 15M93/42 Varex Imaging SSMC SET 502, 1006, 15M93/42 Varex Imaging SSMC SET 506, 100193/42 Varex Imaging SSMC SET 601, 10012 refs93/42 Varex Imaging SSMC SET 601, 1001, 10M2 refs93/42 Varex Imaging SSMC SET 601, 1001, 15M93/42 Varex Imaging SSMC SET 601, 1001, 20M93/42 Varex Imaging SSMC SET 609, 1002, 25M93/42 Varex Imaging SSMC SET 609, 1006 CONFIG 01, 20M93/42 Varex Imaging SSMC SET 609, 1006, 20M93/42 Varex Imaging SSMC SET 610, 1001, 15M93/42 Varex Imaging SSMC SET 616, 100193/42 Varex Imaging SSMC SET 617, 100193/42 Varex Imaging SSMC SET 621, 1001, 18M93/42 Varex Imaging SSMC SET 621, 1001, HMC93/42 XRpad2 3025 HWC-M3 refs	IIa, IIb MDR, 93/42	Website customercare@vareximaging.com EUDAMED record Report an error
Sun Nuclear FDA EU representative : Sun Nuclear GmbH (Germany)	United States	161B/162A Collimator and Beam Alignment Test Tools 405 GSX Precision Resolution Phantom 405GSXLE AAPM CT Performance Phantom 610 Advanced Electron Density Phantom 1467 Advanced iqMODULES 1464 20 others CT ACR 464 Phantom CT Dose Index Phantom 468 CT Perfusion Phantom 432 Doppler 403 Flow Phantom 1425B IQphan 2464 Low Contrast Test Tool 200 M3DP, Mammo 3D Performance Kit Mammo 145 FFDM Phantom Mammo 156 Phantom Mammo 156D Stereo Phantom Mercury 4.0 Phantom 3853 Mini-Doppler Flow Phantom 1430 LE Multi-Energy CT Phantom 1472 Precision Multi-Purpose Grey Scale Phantom 403GS LE SNC Phantom 1250 kV-QA SNC Phantom 1251 MV-QA SNC Phantom FS-QA 1252 SNC Phantom WL-QA 1253 Solid Water HE 557 Sono404 Small Parts Phantom 404GS LE	I MDR	Website EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany)	Japan	FDR Visionary Suite3 refs Mobile X-ray System FDR Go2 refs Mobile X-ray System MobileDaRt Evolution3 refs Mobile X-ray System Mobirex i92 refs RADspeed Pro3 refs	IIb MDR	Website EUDAMED record Report an error
PROTEC X-ray Systems	Germany	Bucky3 refs Bucky WR3 refs Grid entity3 refs Grid entity WR3 refs	I MDR	Website info@protec-med.com EUDAMED record Report an error
Bontech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	BT-DA12M, Pinkview-UPS BT-DA24-IA, BT-DB24-IA, BT-DA22-IA, BT-DB22-IA, BT-DA22W, BT-DB22W3 refs	IIa MDR	Website EUDAMED record Report an error
Integral Medical FDA	Germany	DBF 0503 00012 refs OKS MT100 0305 0001	I MDR	Website info@integral-medical.de EUDAMED record Report an error
Jpi FDA EU representative : Emergo Europe B.V. (Netherlands)	South Korea	Grid-1000 Grid-2100	I MDR	Website EUDAMED record Report an error
Hemodia FDA	France	SET DE PROCEDURE RADIOLOGIE2 refs	I MDR	EUDAMED record Report an error
Klarity Medical & Equipment（GZ） EU representative : Lotus NL B.V. (Netherlands)	China	ARSG-E1A, ARSG-E3A2 refs	IIb MDR	sales@klarity-medical.com EUDAMED record Report an error
Sterisets	Portugal	Various pack Radiology *S93/42	IIa 93/42	Website info@sterisets.com EUDAMED record Report an error
SYNDEO Medical FDA	Belgium	Interventional Radiology INV 023 refs	IIa 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) 27

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
Sedecal., Sa. Present in Europe in other categories	United States	SEDECAL	registered
SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. Present in Europe in other categories	United States	EDITOR HFe	registered
Carestream Health, Inc. Present in Europe in other categories	United States	QG-40-2 QG-40-SE QG-80 QG-50-2 QG-32-3 QG-50-SE	registered
DRGEM Corporation Present in Europe in other categories	South Korea	DRGEM	registered
Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd Present in Europe in other categories	China	S Spellman High Voltage Electronics Corporation	registered
Communications & Power Industries Canada, Inc.	Canada	CMP 200 DR Indico IQ CMP 150 RAD MOBILE NANO MOBILE DR CMP200 DR	registered
Iray Imaging Technology (Haining) Limited	China	iRay	registered
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT	–	Delta	registered
Philips Medical Systems Dmc GmbH Present in Europe in other categories	Germany	XS-100 Generator Certeray iX Velara R/F 2T Velara GCF 2T Velara CVFD CT XS Generator	registered
EMD Technologies	Canada	Epsilon High Voltage Generator Epsilon High Volatge Generator	registered
Del Medical, Inc.	United States	Del Medical, Inc.	registered
ECOTRON Present in Europe in other categories	South Korea	–	registered
GE Medical Systems Present in Europe in other categories	United States	Senographe Pristina not applicable	K954666 (1995)
Suzhou Powersite Electric Co., Ltd. Present in Europe in other categories	China	Medical X-ray High Frequency High Voltage Generator	registered
CMR X-Ray, LLC	United States	–	registered
Can Technomed Trading LTD.	Canada	–	registered
Carestream Healthcare International Company Limited Present in Europe in other categories	China	–	registered
DRTECH Corporation Present in Europe in other categories	South Korea	–	registered
GE HealthCare Technologies Inc. Present in Europe in other categories	United States	–	registered
Gilardoni S.P.A. Present in Europe in other categories	Italy	–	registered
HEFEI MT MEDICAL CO.,LTD. Present in Europe in other categories	China	–	registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories	Netherlands	–	K925105 (1992)
SG Healthcare Co., Ltd. Present in Europe in other categories	South Korea	–	registered
SHINYOUNG FOR M CO.,LTD. Present in Europe in other categories	South Korea	–	registered
Siemens Healthineers AG Present in Europe in other categories	Germany	–	registered
Spellman GmbH	Germany	–	registered
Summit Industries, Inc. Present in Europe in other categories	United States	–	K850117 (1985)

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