Bioimaging and radiotherapy instruments
Nuclear medicine instruments
EMDN code Z1102
Manufacturers registered in Europe (EUDAMED) 32
- 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.
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) 115
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 |
|---|---|---|---|
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K933513 (1993) |
| Qfix Present in Europe in other categories | United States | InfinityLock™ Alta Encompass™ Leg Extension Symphony™ Alpine Stirrups | registered |
| G E MEDICAL SYSTEMS ISRAEL LTD. | Israel | D750b Discovery NMCT 830 to 850 Upgrade 830 to 860 Upgrade StarGuide | K251153 (2025) |
| RADQUAL, LLC | – | RadQual | registered |
| Syntermed, Inc. | United States | NeuroQ Emory Cardiac Toolbox Cardiac Toolbox | K223422 (2023) |
| DEVICOR MEDICAL PRODUCTS, INC. Present in Europe in other categories | United States | neoprobe | registered |
| Digirad Corp. | United States | Breast Imaging Accessory MEAP Collimator LEHR Collimator PINHOLE Collimator LEAP Collimator Diverging Collimator | K123408 (2013) |
| Ultraspect , Ltd. | Israel | UltraSPECT | K103710 (2011) |
| LUCERNO DYNAMICS, LLC | – | Lara Sensor, Type 6 Lara Reader Lara System, 140 keV Lara Docking Station Lara QC Fixture Lara Sensor, Type 4 | registered |
| Bracco Diagnostics Inc. Present in Europe in other categories | United States | Elution Test Vial Shield Vented Cap for Waste Bottle Waste Bottle Elution Test Vial HeartSee Cardiac PET Processing Software | K243881 (2025) |
| DUOPROSS MEDITECH (KUNSHAN) CO.,LTD. | – | DPS | registered |
| crystal-photonics GmbH | – | Navigator 3 Wired Probe Cable Navigator 3 WirelessPprobe, 13mm Straight Navigator 3 Wired Probe, 14 mm Angled Navigator 3 Control Unit Navigator 3 Wireless Probe Battery Pack Navigator 3 Wired Probe, 13mm Straight | registered |
| Brightonix Imaging Inc. | South Korea | BRIGHTONIX | K250170 (2025) |
| MiE medical imaging electronics GmbH | – | MiE - Gamma Camera Systems ANCORIS SCINTRON ECAM-SCINTRON ECAT Scintron PET | registered |
| Cardiovascular Imaging Technologies | United States | ImagenSPECT ImagenPRO ImagenUniversal | K201933 (2020) |
| Sirtex Medical Inc. | United States | SIR-Spheres Syringe Shield SIR-Spheres V-Vial Holder SIROS D-Vial Prep Set SIR-Spheres® Microspheres Activity Calculator (SMAC) | K202392 (2020) |
| Theragenics Corp. | United States | I-Seed Agx100 TheraSeed | registered |
| W.O.M. World of Medicine GmbH | United States | GAMMA FINDER® III Gamma Finder Sterile Sleeve Gamma Finder® II | registered |
| CMR Naviscan Corporation | United States | LumaGEM MBI System | registered |
| PINESTAR TECHNOLOGY, INC. | – | Pinestar Technology Inc | registered |
| CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD Present in Europe in other categories | China | Ophthalmic Ultrasound Examination Instrument | registered |
| Canon, Inc. Present in Europe in other categories | United States | PET-CT SCANNER TOSHIBA SCANNER | registered |
| STANDARD IMAGING INC. Present in Europe in other categories | United States | Standard Imaging HDR 1000 Plus Standard Imaging IVB 1000 Well Chamber | K013548 (2001) |
| Sanders Medical Products, Inc. | United States | Sanders Medical Products | registered |
| Shimadzu Corp. Present in Europe in other categories | United States | PositView SET-5002 | registered |
| Sonoscape Medical Corp. Present in Europe in other categories | China | Sonoscape | registered |
| UIH TECHNOLOGIES LLC | United States | uMI VM uMI | registered |
| X3d ApS | Denmark | CardioMD CorCam | registered |
| Bard Peripheral Vascular, Inc. | – | GAMMA FINDER® | registered |
| Combinostics OY | Finland | cNeuro cPET | K231576 (2023) |
| Covidien, LLC Present in Europe in other categories | United States | Auto Suture | registered |
| INTRA MEDICAL IMAGING LLC | United States | Node Seeker 2000 | registered |
| MULTIFUNCTIONAL IMAGING, LLC | United States | mfiVerse | registered |
| Medimage, Inc. | United States | DELTAmanager | K946334 (1995) |
| Medtec, Inc. Present in Europe in other categories | United States | ZiFix Traverse | registered |
| Radialis Inc | Canada | RADIALIS PET IMAGER | K214062 (2022) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | Biograph mMR | registered |
| Subtle Medical, Inc. Present in Europe in other categories | United States | SubtlePET | K211964 (2021) |
| Surgiceye GmbH | Germany | declipse®SPECT | K133781 (2014) |
| 20MED PTE LTD | Singapore | – | registered |
| AADCO MEDICAL, INC. | United States | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| CLERAD | France | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Canon Medical Systems Corporation Present in Europe in other categories | Japan | – | K251370 (2025) |
| Change Healthcare Canada Company Present in Europe in other categories | Canada | – | registered |
| DATA SPECTRUM CORPORATION | United States | – | registered |
| Digirad Diagnostic Imaging | United States | – | registered |
| Digit Systems SpA | Chile | – | registered |
| E-Z-Em, Inc. | United States | – | registered |
| EURORAD DEUX SIX | France | – | registered |
| Ebayga Radiation Shielding Technology (Shanghai) Co., Ltd | China | – | registered |
| Elekta , Ltd. Present in Europe in other categories | United Kingdom | – | registered |
| Epsilon Elektronik Sanayi ve Tic A.S | Türkiye | – | registered |
| ErgoDenta ApS | Denmark | – | registered |
| Ever Fortune.Ai, Co., Ltd. | Taiwan | – | K213731 (2022) |
| EverX / Bindra | Australia | – | registered |
| Everx Japan Co. Ltd | Japan | – | registered |
| FLEXRAY MEDICAL | Denmark | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Foamtec International Co., Ltd. | Thailand | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GE Healthcare Present in Europe in other categories | United States | – | K223212 (2023) |
| General Equipment For Medical Imaging (Oncovision- | Spain | – | K162052 (2016) |
| Gexpro, A Division of Rexel USA, Inc. | United States | – | registered |
| HM Product Solutions, Ltd. | United States | – | registered |
| I-Tek Medical, Inc. | United States | – | registered |
| IONIC HEALTH TECHNOLOGIES S/A Present in Europe in other categories | Brazil | – | registered |
| ISOTOPE PRODUCTS LABORATORIES | United States | – | registered |
| Kuehne GmbH | Germany | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| LJ Business Corporation | Japan | – | registered |
| Lightpoint Surgical Ltd | Spain | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Mcgovern Medical School | United States | – | K231731 (2023) |
| Medical Resale PTY Limited | Australia | – | registered |
| Medicaps Co., Ltd | South Korea | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Microstructure Imaging, Inc. | United States | – | K261305 (2026) |
| Mie America, Inc. | United States | – | K053086 (2006) |
| Miegmbh | Germany | – | K201807 (2020) |
| Mim Software, Inc. Present in Europe in other categories | United States | – | registered |
| Mirion Technologies, Inc. | United States | – | registered |
| Modo Inc | United States | – | registered |
| NINGBO TIANBO FIRST AID PRODUCT CO., LTD. Present in Europe in other categories | China | – | registered |
| Neusoft Positron Medical Systems Co., Ltd. | China | – | K090178 (2009) |
| Nihon Kohden America, Inc. Present in Europe in other categories | United States | – | registered |
| Nortech Systems, Inc. | United States | – | registered |
| Novanta Medical GmbH Present in Europe in other categories | Germany | – | registered |
| PROBO Medical SAS | France | – | registered |
| PTW Freiburg | Germany | – | registered |
| Prescient Imaging, LLC | United States | – | K210450 (2021) |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| RBM SERVICES, LLC. | United States | – | registered |
| Radiation Products Design, Inc. | United States | – | registered |
| Radium Incorporated | United States | – | registered |
| Raysolution Healthcare Co., Ltd. | China | – | K241266 (2025) |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
The 100 most active manufacturers are shown, out of 115.
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