Bioimaging and radiotherapy instrumentsDigital bioimaging management instruments
Various digital bioimaging management instruments
EMDN code Z110690
Manufacturers registered in Europe (EUDAMED) 23
- 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 SPINE LLC | – | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM Timberline® MPF Lateral Interbody Modular Plate Fixation System | registered |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | Merit Medical® Excite™ | registered |
| Icad, Inc. | United States | PowerLook PRO Tomo Detection and SLD, GE Powerlook PRO Hardware Upgrade, SLD PowerLook AMP PRO, SLD, GE, ROW PowerLook Tomo Detection Software PowerLook AMP SLD Siemens OUS PowerLook PRO Tomo Detection FRU | K240417 (2024) |
| Riverain Technologies, Inc. Present in Europe in other categories | United States | ClearRead Detect Docker ClearRead Xray Detect ClearRead +Detect ClearRead Xray Detect ClearRead Detect Server | registered |
| Faxitron Bioptics, LLC | United States | Faxitron Faxitron Path Faxitron OR Faxitron Core | K183142 (2019) |
| AirLife Finland Oy Present in Europe in other categories | – | Vital Signs™ | registered |
| St Jude Medical | United States | VantageView™ | K110085 (2011) |
| Kubtec Present in Europe in other categories | – | KUBTEC XPERT80 XPERT80L XPERT42 XPERT40 XPERT84 | registered |
| LIVANOVA USA, INC. Present in Europe in other categories | Germany | Datapad ESSENZ Connect | K212003 (2021) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Industries, Inc. | registered |
| QVIEW MEDICAL | United States | QVCAD System QVCAD System Installation Kit | P150043 (2017) |
| Screenpoint Medical B.V. Present in Europe in other categories | Netherlands | Transpara | K260898 (2026) |
| CARROT MEDICAL, LLC | United States | C-View® Pro System C-View® Platinum System C-View® Plus System C-View® Pro-S System C-View® Lite System | registered |
| Overjet, Inc. Present in Europe in other categories | United States | Overjet Caries Assist Overjet Periapical Radiolucency Assist Overjet Calculus Assist Overjet Caries Assist-Pediatric | K261059 (2026) |
| QUIBIM SOCIEDAD LIMITADA. | – | QP-Prostate® CAD | registered |
| DeepHealth, Inc. Present in Europe in other categories | United States | Saige-Dx ProFound Pro Mammo Dx | K253825 (2026) |
| MURATA VIOS, INC. | United States | Vios Monitoring System Mobile Application Vios Monitoring System Central Station Monitor Vios Monitoring System Central Server | registered |
| ZOLL Medical Corporation Present in Europe in other categories | United States | ZOLL Code Writer ZOLL ePCR iOS | K132488 (2014) |
| CIRDAN IMAGING LIMITED Present in Europe in other categories | United Kingdom | Solas OR CoreLite | K213691 (2021) |
| CompAI Healthcare (Suzhou) Co.,ltd | China | TrueView | K230140 (2023) |
| CompAI MedTech (Suzhou) Co., Ltd. | China | TrueView | registered |
| Covidien, LLC Present in Europe in other categories | United States | Vital Sync | registered |
| Imagen Technologies, Inc. | United States | Chest-CAD ChestSuite | K230085 (2023) |
| PARASCRIPT, LLC | – | Parascript® AccuDetect® | P120004 (2015) |
| Pearl, Inc. Present in Europe in other categories | United States | Second Opinion | K250525 (2025) |
| Philips Medical Systems Hsg | – | – | registered |
| Shenyang Torch-Bigtide Digital Technology Co., Ltd. Present in Europe in other categories | China | BIGTIDE | K201162 (2020) |
| Therapixel Present in Europe in other categories | France | MammoScreen | K260714 (2026) |
| BENCH7 INC. | United States | SugarBot | K250264 (2025) |
| Bot Image, Inc. | United States | Bot Image, Inc. | registered |
| CARESTREAM DENTAL LLC Present in Europe in other categories | United States | Logicon Caries Detector | P980025 (2019) |
| Carestream Health, Inc. Present in Europe in other categories | United States | Logicon Caries Detector | P030007 (2007) |
| Clarix Imaging Corporation | United States | Clarix Imaging Corps | K192939 (2019) |
| CompAI Healthcare (Shenzhen) Co.,ltd | China | TrueView | K202713 (2020) |
| DEEPTEK MEDICAL IMAGING PRIVATE LIMITED Present in Europe in other categories | India | DeepTek CXR Analyzer | registered |
| DGNCT LLC Present in Europe in other categories | United States | Diagnocat | K252934 (2026) |
| Eizo Corporation Present in Europe in other categories | Japan | CuratOR | K112645 (2011) |
| GLEAMER Present in Europe in other categories | France | ChestView US | K252486 (2026) |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | CARESCAPE CENTRAL STATION | K133882 (2014) |
| QURE.AI TECHNOLOGIES PRIVATE LIMITED Present in Europe in other categories | India | qXR-LN | registered |
| SEE-MODE TECHNOLOGIES PTE. LTD. | Singapore | See-Mode Technologies | K260303 (2026) |
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | – | K201560 (2021) |
| Velmeni, Inc. Present in Europe in other categories | United States | Velmeni for Dentists | K252953 (2026) |
| Videahealth, Inc. Present in Europe in other categories | United States | Videa Dental Assist | K251002 (2025) |
| Vucomp, Inc. | United States | M-Vu Algorithm Engine | registered |
| ARTHREX, INC. Present in Europe in other categories | United States | – | registered |
| AZmed Present in Europe in other categories | France | – | K243831 (2025) |
| Abbott Laboratories Present in Europe in other categories | United States | – | K760721 (1976) |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BeamWorks, Inc. | South Korea | – | K260086 (2026) |
| Better Diagnostics AI Corp. | United States | – | K260851 (2026) |
| Brainlab AG Present in Europe in other categories | Germany | – | registered |
| Cube Click, Inc. | United States | – | K242437 (2025) |
| DENTSPLY SIRONA INC | United States | – | K261072 (2026) |
| DRTECH Corporation Present in Europe in other categories | South Korea | – | registered |
| Deeptek Medical Imaging Pvt, Ltd. | India | – | K231001 (2023) |
| Denti.Ai Technology, Inc. | Canada | – | K230144 (2023) |
| Exo, Inc. | United States | – | K243239 (2025) |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GE Healthcare Present in Europe in other categories | United States | – | K162012 (2016) |
| GWW | Germany | – | registered |
| Imidex, Inc. | United States | – | K223133 (2023) |
| Kub Technologies, Inc. Present in Europe in other categories | United States | – | K210955 (2021) |
| Median Technologies | United States | – | K251474 (2026) |
| Nobel Biocare C/O Medicim NV | Belgium | – | K252086 (2025) |
| Olympus America, Inc. Present in Europe in other categories | United States | – | registered |
| Philips Medizin Systeme Boeblingen GmbH | Germany | – | K212208 (2021) |
| Quantib B.V. Present in Europe in other categories | Netherlands | – | K253682 (2026) |
| Qure.Ai Technologies | India | – | K251934 (2026) |
| Qure.Ai Technologies Pvt. , Ltd. | India | – | K261517 (2026) |
| SCANMED, LLC Present in Europe in other categories | United States | – | K212783 (2022) |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | – | K170460 (2017) |
| TECHNICAL SERVICES FOR ELECTRONICS, INC. | United States | – | registered |
| Taihao Medical, Inc. Present in Europe in other categories | Taiwan | – | K210670 (2021) |
| Tribe Medical Group | Canada | – | registered |
| Vios Medical, Inc. | United States | – | K173107 (2018) |
| XEOS Medical Present in Europe in other categories | Belgium | – | registered |
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