Bioimaging and radiotherapy instrumentsVarious bioimaging and radiotherapy instruments
Various bioimaging and radiotherapy instruments - medical device software
EMDN code Z119092
Manufacturers registered in Europe (EUDAMED) 18
- 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) 78
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) |
| Medcad | United States | AccuPlan System AccuModel AccuPlan® System AccuModel® | K223024 (2023) |
| 3D Systems, Inc. | United States | VSP System VSP System, VSP Cranial | K261826 (2026) |
| Synthes GmbH Present in Europe in other categories | United States | MatrixMANDIBLE Matrix MatrixMIDFACE | registered |
| Stryker Leibinger GmbH & Co. KG Present in Europe in other categories | Germany | DELTA | registered |
| FUSION ORTHOPEDICS, LLC | United States | PolyLock Midfoot FuzeFix Chamfered Screws PolyLock FuzeFix Max FT | registered |
| HARRISON-AI MEDICAL PTY LTD Present in Europe in other categories | Australia | Annalise Triage Annalise Enterprise Annalise Critical Care AI | registered |
| MeVis Medical Solutions AG Present in Europe in other categories | United States | Veolity Visia LungCAD DynaCAD Lung Server Veolity LungCAD DynaCAD Lung | K201501 (2021) |
| 3D LIFEPRINTS UK LTD | United Kingdom | EmbedMed | K220366 (2022) |
| Aidoc Medical , Ltd. Present in Europe in other categories | Israel | BriefCase Triage | K243548 (2024) |
| STRYKER CORPORATION Present in Europe in other categories | United States | TPX | K943540 (1994) |
| GE Medical Systems Present in Europe in other categories | United States | Critical Care Suite | K183182 (2019) |
| Ischemaview, Inc. Present in Europe in other categories | United States | Rapid | K230074 (2023) |
| NANO-X AI LTD Present in Europe in other categories | Israel | HealthPNX HealthPPT HealthMammo | registered |
| Propel Orthodontics, LLC | United States | Propel | K172164 (2018) |
| Coreline Soft Co., Ltd. Present in Europe in other categories | South Korea | AVIEW Lung Nodule CAD | K251203 (2025) |
| Lunit, Inc. Present in Europe in other categories | South Korea | Lunit INSIGHT CXR Triage | K211733 (2021) |
| Medcognetics, Inc. | United States | Cognet AI | K252482 (2025) |
| Viz. Ai, Inc. Present in Europe in other categories | United States | Viz AAA Viz ANEURYSM | K223443 (2023) |
| Avicenna.Ai Present in Europe in other categories | France | CINA-VCF | K240612 (2024) |
| Curemetrix, Inc. | United States | cmTriage | K183285 (2019) |
| Dental Wings GmbH Present in Europe in other categories | Germany | coDiagnostiX | K193301 (2021) |
| INSTITUT STRAUMANN AG Present in Europe in other categories | Switzerland | CoDiagnostiX | registered |
| Infervision Medical Technology Co., Ltd Present in Europe in other categories | China | InferRead Lung CT.AI | K240554 (2025) |
| Infervision US Inc Present in Europe in other categories | United States | InferRead Lung CT.AI 2.1.2.1 | registered |
| Milvue Present in Europe in other categories | France | SmartChest | K232410 (2024) |
| QURE.AI TECHNOLOGIES PRIVATE LIMITED Present in Europe in other categories | India | qXR-PTX-PE | registered |
| VUNO Inc. Present in Europe in other categories | South Korea | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | K241439 (2024) |
| ZSQUARE LTD | Israel | Zsquare ENT-Flex Imaging Core | registered |
| AZmed Present in Europe in other categories | France | – | K243808 (2025) |
| Acumed LLC | United States | – | registered |
| Annalise-Ai Pty , Ltd. | Australia | – | K250831 (2025) |
| Avalign Instruments & Implants | United States | – | registered |
| Baechler Feintech AG | Switzerland | – | registered |
| Behold.Ai Technologies Limited | United Kingdom | – | K191556 (2020) |
| Beijing Infervision Technology Co., Ltd. | China | – | K192880 (2020) |
| Bering, Ltd. | United Kingdom | – | K223754 (2023) |
| Centermed, Inc. | United States | – | K201353 (2021) |
| DENTSPLY SIRONA INC | United States | – | registered |
| Envisionit Deepai, Ltd. | United Kingdom | – | K231871 (2024) |
| Ever Fortune.Ai, Co., Ltd. | Taiwan | – | K221552 (2022) |
| Fujifilm Corporation Present in Europe in other categories | Japan | – | K254075 (2026) |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| Hipp Medical AG Present in Europe in other categories | Germany | – | registered |
| Hologic, Inc. Present in Europe in other categories | United States | – | K043617 (2007) |
| Immersivetouch | United States | – | K181813 (2020) |
| Jabil Inc. | United States | – | registered |
| KLS Martin Manufacturing, LLC | United States | – | registered |
| NEUROCAREAI INC | United States | – | registered |
| Neurocareai, Inc. (Dba Savelife.Ai) | United States | – | K253751 (2026) |
| OSTEOMED LLC | United States | – | K212570 (2022) |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| Precision Edge Surgical Products Company | United States | – | registered |
| Proto-Med, Inc. | United States | – | K193499 (2020) |
| Quanta Computer, Inc. | Taiwan | – | K221868 (2023) |
| Qure.Ai Technologies | India | – | K230899 (2023) |
| Radlogics, Inc. | United States | – | K193300 (2020) |
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI | Türkiye | – | registered |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | – | registered |
| Shanghai United Imaging Intelligence Co., Ltd. Present in Europe in other categories | China | – | K193271 (2021) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | – | K231157 (2023) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K193216 (2020) |
| Sphinx Tools Ltd | Switzerland | – | registered |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | – | registered |
| Synthes (USA) Products, LLC Present in Europe in other categories | United States | – | K150796 (2015) |
| Techfit Digital Surgery, Inc. | United States | – | K242263 (2024) |
| Techmah Cmf | United States | – | K231520 (2023) |
| The Anspach Effort, Inc. | United States | – | registered |
| Unique Instruments Inc. | United States | – | registered |
| V5med, Inc. | Taiwan | – | K242919 (2025) |
| Varex Imaging Corporation Present in Europe in other categories | United States | – | registered |
| Vha Dean | United States | – | K220648 (2022) |
| Vinbigdata Joint Stock Company | Vietnam | – | K233108 (2024) |
| Vinbrain Joint Stock Company | Vietnam | – | K221241 (2022) |
| W&H Dentalwerk Buermoos GmbH | Austria | – | registered |
| Zebra Medical Vision, Ltd. | Israel | – | K211803 (2021) |
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