Bioimaging and radiotherapy instruments

Magnetic resonance imaging (MRI) instruments

EMDN code Z1105

29 manufacturers, 175 models including 174 on the market, 7 countries

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

Manufacturers registered in Europe (EUDAMED) 29

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
Shanghai Chenguang Medical Technologies FDA EU representative : Lotus NL B.V. (Netherlands)	China	ANTERIOR-SYN HEAD/NECK COIL93/42 Circ.CoiL C1-II 1.0T93/42 Circ.CoiL C1-II 1.5T93/42 Circ.CoiL C3 1.5T93/42 DRIVERBOX-SYN HEAD/NECK COIL2 refs93/42 33 others dS Ped.Head-spine 8ch 1.5T93/42 dS Ped.Head-spine 8ch 3.0T93/42 dS Ped.TorsoCardiac 8ch 1.5T93/42 dS Ped.TorsoCardiac 8ch 3.0T93/42 Knee/Foot coil93/42 MICRO 23MM COIL93/42 MICRO 47MM COIL93/42 Pediatric Body-Cardiac Coil2 refs93/42 Pediatric Head-Spine Coi93/42 Pediatric Head-Spine Coil93/42 POSTERIOR-SYN HEAD/NECK COIL93/42 QUAD HEAD COIL 1.5T2 refs93/42 SENSE CARDIAC COIL 1.5T2 refs93/42 SENSE FLEX L COIL 1.5T93/42 SENSE FLEX L COIL 3.0T93/42 SENSE FLEX M COIL 1.5T2 refs93/42 SENSE FLEX M COIL 3.0T93/42 SENSE FLEX S COIL 1.5T2 refs93/42 SENSE FLEX S COIL 3.0T93/42 SENSE FLEX-L COIL 1.5T VEAM93/42 SENSE SPINE COIL 1.5T2 refs93/42 SHNC Anterior part (1.0T)93/42 SHNC DRIVERBOX 1.0T93/42 SHNC DRIVERBOX 1.5T ODU93/42 SHNC Posterior part (1.0T)93/42 SYN. BODY COIL2 refs93/42 SYN. BODY COIL 1.0T93/42 SYN. BODY COIL 1.5T2 refs93/42 SYN. BODY COIL 1.5T ODU2 refs93/42 SYN. BODY COIL 1.5T ODU WITH SLEEVE93/42 T/R HEAD COIL 3.0T93/42 T/R HEAD COIL 1.5T(QHC 1H T/R ACS-NT-L)93/42 Wrist/Hand coil93/42	IIa, III 93/42	EUDAMED record Report an error
GE Healthcare FDA EU representative : GE Medical Systems SCS (France)	China, United States	1.5T 12 Channel Body Array 1.5T Body Arrays3 refs 1.5T 16ch AIR AA 1.5T 4ch Large Flex Coil 1.5T 4CH Flex coils2 refs 1.5T AIR MP L 1.5T AIR MP M 32 others 1.5T Express Coil – 16E Head Neck Array 1.5T Express Coils 9E AA and 16E HNS Array2 refs 1.5T GEM Anterior Array 1.5T GEM Coil Suite3 refs 1.5T HD 8 CHANNEL CTL COIL 1.5T HD 8CH CARDIAC ARRAY 1.5T HD FLAT GEM TABLE BREAST ARRAY 1.5T and 3.0T HD Breast Arrays3 refs 1.5T HD SHOULDER ARRAY 1.5T and 3.0T HD Shoulder Arrays3 refs 1.5T TDI and Anterior Array3 refs 3.0T 16ch AIR AA 3.0T 16ch HEAD NECK SPINE (HNS) ARRAY 1.5T and 3.0T Head Neck Spine (HNS) Arrays2 refs 3.0T 48CH Head Coil3 refs 3.0T 8CH HD TORSO ARRAY 3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL3 refs 3.0T AIR MP L 3.0T AIR MP M 3.0T GEM Anterior Array 3.0T GEM Suite3 refs 3.0T HD 8CH CARDIAC ARRAY 3.0T HD 8CH CTL ARRAY 3.0T HNU / UAA / LAA3 refs Discovery 3.0T 32CH Body Array Coil2 refs Express Coil – Anterior Array 1.5T Express Coils2 refs GE 8ch Foot Ankle coil SIGNA Artist SIGNA Artist Evo SIGNA Champion SIGNA Creator SIGNA Explorer SIGNA Prime SIGNA Prime Elite SIGNA Sprint SIGNA Victor SIGNA Voyager TDI Head Neck/ Posterior Array and 3.0T AA3 refs	I, IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Esaote FDA	Italy	CERVICAL COIL N.143 refs G-scan Brio 10100293/42 G-scan Brio Premium 10000293/42 G-scan MSK 1000013 refs G-scan Open 1000013 refs 7 others I-Genius 100019 Magnifico MSK 100009 MRI EVOlution 24 1000093 refs O-Scan 10100393/42 O-scan Smart 100002 S-scan 98000293/42 S-scan Premium 10000293/42	I, IIa MDR, 93/42	qa@esaote.com EUDAMED record Report an error
GE Medical Systems FDA EU representative : GE Medical Systems SCS (France)	United States	1.5T GP Flex Coil 1.5T HDxt Upgrade Kit 3.0T GE 6-Channel Phased Array Flex Coil 1.5T and 3T 6 Channel Phased Array Flex Coil2 refs 3” Round Coil 1.5T 5” Round Coil 1.5T 6 others DISCOVERY MR 450- 1.5T SPLIT HEAD COIL 1.5T and 3.0T Split Head Coil2 refs SIGNA 7.0T SIGNA Architect SIGNA Hero SIGNA Pioneer SIGNA Premier	I, IIa MDR	eudamed@gehealthcare.com EUDAMED record Report an error
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	uMR 580 uMR 588 uMR 670 uMR 680 uMR 7802 refs 4 others uMR Astra uMR Jupiter uMR Omega uMR Ultra	IIa MDR, 93/42	services@united-imaging.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan	AIRIS Vento AIRIS Vento MSK93/42 APERTO Lucent APERTO Lucent MSK93/42 ECHELON Smart 2 others ECHELON Synergy OASIS	IIa MDR, 93/42	EUDAMED record Report an error
Shenzhen Basda Medical Apparatus EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Bstar-05093/42 Bstar-07093/42 Bstar-15093/42 BTI-02093/42 BTI-03093/42 2 others BTI-03593/42 BTI-05093/42	IIa 93/42	EUDAMED record Report an error
NeoCoil FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	1.5T 16ch Breast Coil2 refs 1.5T 16ch Shoulder Coil2 refs 1.5T AIR Open Head Anterior 16ch 32Ch AIR Open Coil3 refs 1.5T HD 8Ch Shoulder Coil2 refs 1.5T Receive-Only 16ch Flex SPEEDER Large 16ch Flex SPEEDER Coils3 refs 1 other GEM Flex Coil 16-L Array, 1.5T Receive Only3 refs	I MDR	EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	China, Netherlands	BlueSeal QE3 refs Marlin 1.5T3 refs MR coil (Smart Fit Knee 3.0T) MR coils (dS TorsoCardiac 1.5T/dS MSK S 1.5T/dS MSK M 1.5T)3 refs MR coils (Smart Fit Shoulder 1.5T/Smart Fit TorsoCardiac 1.5T)2 refs 1 other Options IB Prodiva 1.5T R53 refs	IIa, IIb MDR	eudamed@philips.com EUDAMED record Report an error
Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands)	China	Magnetic Resonance Imaging System Supernova 1.5T93/42 Supernova 516W93/42 Supernova C593/42 Supernova OS593/42	IIa MDR, 93/42	EUDAMED record Report an error
Liebel-Flarsheim FDA EU representative : Guerbet (France)	United States	Optistar Optistar 81400193/42 Optistar 81400293/42 Optistar 81400493/42 Optistar 81400593/42	IIb MDR, 93/42	EUDAMED record Report an error
Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ASM-030PIII(OPENMARK III) ASM-040P(OPENMARK 4000)93/42 ASM-050P(OPENMARK 5000)93/42 SuperMark 1.5T93/42	IIa MDR, 93/42	EUDAMED record Report an error
DxTx Medical FDA EU representative : MedR-AR Services B.V. (Netherlands)	United States	3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) BPX 1593/42 Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®) BPX 3093/42 Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens BPX 30 NG-S	I, IIa MDR, 93/42	Website EUDAMED record Report an error
ASG Superconductors FDA	Italy	MR Open EVO MROpen EVO V493/42 MRopen EVO MROpen Evo 03-2000-003 refs	IIa MDR, 93/42	info@as-g.it EUDAMED record Report an error
Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Scope, i_Scope X, i_Scope XT i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro	IIa MDR	EUDAMED record Report an error
Alltechmed FDA EU representative : Caretechion GmbH (Germany)	China	EchoStar 1.5T93/42 EchoStar Comfort 1.5T93/42	IIa 93/42	sales@alltechmed.com EUDAMED record Report an error
Medtron	Germany	Accutron MR INJMR Accutron MR3 INJMR3	IIb MDR	Website info@medtron.com EUDAMED record Report an error
Siemens Shenzhen Magnetic Resonance FDA EU representative : Siemens Healthcare GmbH (Germany)	China	MAGNETOM Amira MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom3 refs MAGNETOM Amira MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom3 refs	IIa MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Bayer FDA EU representative : Bayer Medical Care B.V. (Netherlands)	United States	MEDRAD® MRXperion MR Injection System MEDRAD® Spectris Solaris EP MR Injection System (no longer marketed)	IIb MDR	EUDAMED record Report an error
Antmed FDA EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	Contrast Media Injectors ANT065115	IIb MDR	Website info@antmed.com EUDAMED record Report an error
Canon FDA EU representative : Canon Medical Systems Europe B.V. (Netherlands)	Japan	MRT-3020, MRT-1550, etc.3 refs	IIa MDR	eudamed-info@mail.canon EUDAMED record Report an error
Hyperfine FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Swoop Portable MR Imaging System 850-11001-06 (900-11001-06, in crate)3 refs	IIa MDR	Website eudamed@hyperfine.io EUDAMED record Report an error
LMT Medical Systems FDA	Germany	NBAC 1.5T PH I Flex3 refs	IIa MDR	Website info@lmt-medicalsystems.com EUDAMED record Report an error
Neoscan Solutions FDA	Germany	neo315	IIa MDR	Website info@neoscan-solutions.com EUDAMED record Report an error
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands)	China	NeuMR 1.5T	IIa MDR	EUDAMED record Report an error
Quality Electrodynamics FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	16ch T/R Knee Coil3 refs	IIa MDR	Website EUDAMED record Report an error
Siemens Healthcare FDA	Germany	MAGNETOM Aera MDR_02_IIa_ERLN H 127_ACDV_Magnetom3 refs	IIa MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthineers FDA	Germany	MAGNETOM Altea MDR_02_IIa_FOR AG S3_ACDV_Magnetom3 refs	IIa MDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Time Medical FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	Pica TMS-MRI-3500WB93/42	IIa 93/42	info@time-medical.com 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) 65

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
Noras Mri Products GmbH Present in Europe in other categories	Germany	Breast BI 7 MR Coil Set 3T NORAS OR HEADCOIL Top Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Bottom Array Siemens 1.5T NORAS OR HEADCOIL Bottom Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Top Array Philips 3T NORAS OR HEAD COIL Top Array Siemens 1.5T	K241069 (2024)
Usa Instruments, Inc.	United States	1.5T AIR Posterior Array	K052916 (2005)
SCANMED, LLC Present in Europe in other categories	United States	ScanMed PROCURE™ Coil ScanMed Knee/Foot Coil ScanMed Elbow Coil ScanMed Blanket Coil ScanMed Shoulder/Knee (M) Coil ScanMed Long Bone (L) Coil	registered
Rapid Biomedical GmbH Present in Europe in other categories	Germany	13C/1H Head Coil 23Na/1H Head Coil 31P/1H Head Coil 1.5T Endorectal Coil 16Ch Diagnostic Breast Coil 31P/1H TxRx Flex Loop 7T	K213480 (2023)
IMRIS Imaging, Inc. Present in Europe in other categories	United States	InVision 1.5 Surgical Theatre InVision™ 1.5T Operating Suite InVision™ 3T Operating Suite InVision™ 3T Recharge Operating Suite IMRIS iMRI 3T V InSitu Coil	registered
Mr Instruments, Inc.	United States	DuoFLEX® Coil Suite 32Ch Head Coil 1.5T DuoFLEX Standard Suite	K173290 (2017)
Shenzhen RF Tech Co., Ltd. Present in Europe in other categories	China	RFT	K252587 (2026)
Monteris Medical,	United States	AtamA™ System AtamA System	K132444 (2014)
Inkspace Imaging, Inc.	United States	Snuggle Pediatric Array InkSpace Imaging Body Array Snuggle Pediatric Array – PH 3T (Dino) Nuzzle Body Array – PH 3T (Whimsical) Silhouette Adult Array Snuggle Pediatric Array, 1.5T	K262813 (2026)
Machnet BV	United States	–	K013985 (2002)
Nova Medical, Inc Present in Europe in other categories	United States	3T 32 CH Head Coil 2Tx32Rx 7T Head Coil 8Tx32Rx 7T Head Coil 1Tx32Rx 7T Head Coil	K182737 (2019)
Hyperfine Operations, Inc.	–	Swoop Transmit and Receive Radio Frequency Head Coil	registered
Promaxo, Inc.	United States	Promaxo MRI System MRI Medium RX Coil (Receive Only) Template Holder with Fiducials	registered
Polarean, Inc.	United States	XENOVIEW 3.0T Chest Coil XENOVIEW 3.0T Chest Coil-GE Premier	K243316 (2024)
BrainSpec Inc.	United States	BrainSpec Core™ Software	registered
ClearPoint Neuro, Inc. Present in Europe in other categories	United States	ClearPoint	registered
MEDSPIRA, LLC	United States	3.0T BC-10 Transmit/Receive MRI Coil 1.5T BC-10 Transmit/Receive MRI Coil	registered
Aspect Imaging, Ltd.	Israel	Embrace Neonatal MRI System	registered
20MED PTE LTD	Singapore	–	registered
AGITO Medical A/S	Denmark	–	registered
Anzai Medical Co., Ltd.	Japan	–	registered
Avnet, Inc.	United States	–	registered
BENCHMARK ELECTRONICS, INC.	United States	–	registered
Block Imaging SAS	United States	–	registered
Cablon Medical B.V. Present in Europe in other categories	Netherlands	–	registered
Can Technomed Trading LTD.	Canada	–	registered
Creative Foam Corporation	United States	–	registered
DHL Supply Chain (Netherlands) B.V.	Netherlands	–	registered
DirectMed Imaging, LLC	United States	–	registered
EVOLVE MANUFACTURING TECHNOLOGIES INC.	United States	–	registered
Elsmed Ltd.	Israel	–	registered
Everx Japan Co. Ltd	Japan	–	registered
FUJITA CO., LTD.	Japan	–	registered
Greens Surgicals Private Limited	India	–	registered
HM Product Solutions, Ltd.	United States	–	registered
Haywood Vocational Opportunities	United States	–	registered
Hitachi Medical Systems America, Inc. Present in Europe in other categories	United States	–	K162079 (2016)
Hospital & Homecare Imp. & Exp. Co., Ltd	China	–	registered
Insight Medbotics, Inc.	Canada	–	K223484 (2023)
Invivo Corporation Present in Europe in other categories	United States	–	K213766 (2021)
Invivo Corporation (Business Trade Name: Philips) Present in Europe in other categories	United States	–	K232762 (2023)
Invivo Therapeutics Corporation	United States	–	K162863 (2016)
Kuehne GmbH	Germany	–	registered
LBN Medical ApS	Denmark	–	registered
LJ Business Corporation	Japan	–	registered
LifeSync Corporation	United States	–	registered
M-solutions Inc.	Japan	–	registered
MARKEN HEALTHTECH LIMITED	India	–	registered
Makar Consulting Pty Ltd	Australia	–	registered
Mark Enterprises	India	–	registered
Medical Resale PTY Limited	Australia	–	registered
Medivest Group	United Kingdom	–	registered
Moras Mri Products GmbH	Germany	–	K162651 (2017)
P BHOGILAL PVT LTD	India	–	registered
PROBO Medical SAS	France	–	registered
Philips Medical System Nederlands B.V.	Netherlands	–	K233348 (2023)
Qfix Present in Europe in other categories	United States	–	K190668 (2019)
SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.	Japan	–	registered
Scandinavian Medical Solutions A/S	Denmark	–	registered
Shanghai Chenshi Medical Instruments Co., Ltd	China	–	registered
Siaron Medical Ltd	Canada	–	registered
Siemens Medical Solutions USA, Inc. Present in Europe in other categories	United States	–	K962627 (1997)
SteriPack USA (Limited) LLC	United States	–	registered
U.S. Imaging, Inc. Present in Europe in other categories	United States	–	registered
UIH TECHNOLOGIES LLC	United States	–	registered

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