Bioimaging and radiotherapy instruments
Digital bioimaging management instruments
EMDN code Z1106
Manufacturers registered in Europe (EUDAMED) 143
- 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) 244
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 |
|---|---|---|---|
| Carestream Health, Inc. Present in Europe in other categories | United States | LANEX Regular Screens Select Cassette with LANEX Medium Screens Select Cassette with LANEX Regular Screens Imaging Plate LANEX Fine Screens X-OMATIC Regular Screens | P030007 (2007) |
| BIOMET SPINE LLC | – | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM Timberline® MPF Lateral Interbody Modular Plate Fixation System | registered |
| Shining 3D Tech Co., Ltd. | China | SHINING 3D® cameo™ OPERA SYSTEM® INTELLISCAN 3D® Intraoral Scanner SHINING 3D® Intraoral Scanner SHINING3D® | registered |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | Merit Medical® Excite™ | registered |
| ZIRKONZAHN SRL | Italy | Scanner S600 Workstation Scanner S300 Notebook Scanner S900 SC S300 ARTI 230V Messe-allgemein | registered |
| Alliedstar Medical Equipment Co., Ltd. | China | Alliedstar Straumann SIRIOS X3 Alliedstar Sensa NeoScan Dandy Vision | registered |
| 3shape Trios A/S Present in Europe in other categories | Denmark | TRIOS® 3 TRIOS® 4 TRIOS® 3Shape Scan Bodies TRIOS 3 TRIOS Core | registered |
| Flow X Ray Corporation | United States | Wolf X-Ray | registered |
| Claronav, Inc. Present in Europe in other categories | Canada | MicronMapper MicronMapper EVO TissueMapper | 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) |
| Medit Corp. Present in Europe in other categories | South Korea | Medit Link Express Identica Wireless Hub Package Medit Splints PD Cable Package 2m i700 Single use tip | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Visionary by 3D Dental | registered |
| 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 |
| Topcon Healthcare Solutions EMEA Oy Present in Europe in other categories | Finland | Harmony IMAGEnet 6 Glaucoma Module Harmony Referral System | K253893 (2026) |
| TOPCON HEALTHCARE INC Present in Europe in other categories | United States | Harmony Synergy ODM | registered |
| Dental Imaging Technologies Corporation Present in Europe in other categories | United States | IS 3700 I/O 3D Scanner Assembly-IS 3800 POSTERIOR TIP Assembly-IS 3600 POSTERIOR TIP Assembly-IS 3800 SIDE TIP Assembly-DEXIS Imprevo Tip Assembly-IS 3600 NORMAL TIP | 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 |
| KaVo Dental GmbH Present in Europe in other categories | Germany | DIAGNOcam Vision Full HD DIAGNOdent pen 2190 DEXIS CariVu 3-in-1 by KaVo DIAGNOdent 2095 DIAGNOdent Paro Tip Saphir without scale DIAGNOdent pen 2190 US | K060080 (2006) |
| St Jude Medical | United States | VantageView™ | K110085 (2011) |
| 3Shape A/S Present in Europe in other categories | Denmark | Lab Scanner Automate Dental System Anatomy Design | registered |
| Guangdong Launca Medical Device Technology Co., Ltd. | China | Intraoral Scanner Launca | registered |
| Kubtec Present in Europe in other categories | – | KUBTEC XPERT80 XPERT80L XPERT42 XPERT40 XPERT84 | registered |
| Huvitz Co., Ltd. Present in Europe in other categories | South Korea | Huvitz Integrated Image Server HIIS-1 LS-100-TIP LSO-100-TIP IntraOral Scanner Lilivis CAD L-CAD Lilivis Scan LS-100 | K191615 (2019) |
| Nidek, Inc. Present in Europe in other categories | United States | AL-Scan Viewer for NAVIS-EX CEM Viewer for NAVIS-EX Image filing software NAVIS-EX Image filing software Scanning Laser Ophthalmoscope Data Acquisition Service for NAVIS-EX | K181345 (2018) |
| Prismatik Dentalcraft, Inc | United States | fastdesign.io FinalTouch Glidewell Restorative CT | registered |
| DÜRR DENTAL SE Present in Europe in other categories | Germany | CamX Triton HD, Cam CamX Triton HD, Cam Proxi CamX Triton HD, Cam Spectra Proxi CamX Triton HD, PROXI Head CamX Triton HD Handpiece CamX Proxi Interchangeable Head | 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 |
| Ori Inc | United States | Ori | registered |
| QVIEW MEDICAL | United States | QVCAD System QVCAD System Installation Kit | P150043 (2017) |
| Ziyang Freqty Medical Equipment Co., Ltd. | China | Freqty PANDA SCANNER | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| 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 |
| Kulzer, Inc. | United States | Cara | registered |
| Sirona Dental Systems GmbH Present in Europe in other categories | United States | Primescan 2 Primescan 2 Multiuse Sleeve | registered |
| BLUE SKY BIO LLC | United States | Blue Sky Bio, LLC. | registered |
| Changsha Honchon Technology Co., LTD Present in Europe in other categories | China | Intraoral Scanner | registered |
| Chengdu Besmile Medical Technology Co., Ltd. Present in Europe in other categories | China | Intraoral Scanner | registered |
| DDS INC | South Korea | COMFORT+ RAYiOS2 RAYiOS | registered |
| DENTCA, INC. | United States | DENTCA Design | 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) |
| Palodex Group OY Present in Europe in other categories | Finland | KAVO X PRO REUSABLE TIP SUPPORT X PRO KAVO X PRO USB INTERFACE BOX X PRO DISPOSABLE TIP | registered |
| QUIBIM SOCIEDAD LIMITADA. | – | QP-Prostate® CAD | registered |
| exocad GmbH | Germany | Ceramill Mind DRS ChairsideCAD | registered |
| CEFLA SOCIETA' COOPERATIVA | – | NewTom | registered |
| Canon, Inc. Present in Europe in other categories | United States | CANON INC. | K201273 (2020) |
| MURATA VIOS, INC. | United States | Vios Monitoring System Mobile Application Vios Monitoring System Central Station Monitor Vios Monitoring System Central Server | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark True Definition Scanner | registered |
| ZOLL Medical Corporation Present in Europe in other categories | United States | ZOLL Code Writer ZOLL ePCR iOS | K132488 (2014) |
| smart optics Sensortechnik GmbH | Germany | KAVO LS3 | registered |
| 3D IMAGING AND SIMULATION CORP. AMERICAS | – | OVO IOS Heron IOS | registered |
| Addent, Inc. | United States | AdDent | K062961 (2007) |
| Arcreal Inc. | South Korea | arcscan | registered |
| CIRDAN IMAGING LIMITED Present in Europe in other categories | United Kingdom | Solas OR CoreLite | K213691 (2021) |
| Changzhou Sifary Medical Technology Co., Ltd. Present in Europe in other categories | China | Eighteeth | registered |
| 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 |
| Eigen Health Services LLC | – | Artemis-TPOS Artemis | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | EyeSuite Software | K142423 (2014) |
| IMAGOWORKS Inc. | South Korea | Dentbird Crown | registered |
| Imagen Technologies, Inc. | United States | Chest-CAD ChestSuite | K230085 (2023) |
| Imetric 4D Imaging Sàrl Present in Europe in other categories | – | Imetric | registered |
| 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) |
| TUPEL LTD | United Kingdom | Tupel 3D | registered |
| Therapixel Present in Europe in other categories | France | MammoScreen | K260714 (2026) |
| Topcon Corporation Present in Europe in other categories | Japan | IMAGEnet 5 OPHTHALMIC DATA SYSTEM IMAGEnet 6 OPHTHALMIC DATA SYSTEM | K232828 (2024) |
| Trident S.R.L Present in Europe in other categories | Italy | Intraoral Digital Impression Instrument | registered |
| X-Nav Technologies, LLC Present in Europe in other categories | United States | X-Guide FastMap FastMap | registered |
| A-Dec, Inc. | United States | A-dec | registered |
| BENCH7 INC. | United States | SugarBot | K250264 (2025) |
| Bot Image, Inc. | United States | Bot Image, Inc. | registered |
| CIRCLE ANATOSCOPE INTUITIVE DESIGN | France | Circle One | registered |
| COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | – | S4 OPTIK | registered |
| Centervue S.P.A. Present in Europe in other categories | Italy | iCare ALTIUS CW | K234076 (2024) |
| 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 |
| DENTIN IMPLANTS TECHNOLOGIES LTD | Israel | PROSTHETIC SCREWS | registered |
| DGNCT LLC Present in Europe in other categories | United States | Diagnocat | K252934 (2026) |
| Diagnos Inc | United States | CARA | K110869 (2011) |
| ESSILOR INTERNATIONAL Present in Europe in other categories | United States | ANAEYES OCT for system linkage | registered |
| Eizo Corporation Present in Europe in other categories | Japan | CuratOR | K112645 (2011) |
| GLEAMER Present in Europe in other categories | France | ChestView US | K252486 (2026) |
| GNI Co.,Ltd Present in Europe in other categories | South Korea | SS650 | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | CARESCAPE CENTRAL STATION | K133882 (2014) |
| Gro3x, Inc. | – | Gro3X DIU | registered |
| GuidePro3D | – | GuidePro3D | registered |
| Hdx Will Corp. Present in Europe in other categories | South Korea | Real Arch | registered |
| INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | United States | IRIS | K141922 (2015) |
| IVOCLAR VIVADENT AKTIENGESELLSCHAFT | – | Ceramill map DRS | registered |
| Indica Labs, Inc. Present in Europe in other categories | United States | HALO AP Dx | K252762 (2025) |
| Integrated Ophthalmic Systems, Inc. | United States | Continuum PACS | K200385 (2020) |
| JelloX Biotech Inc. | Taiwan | JelloX | K240303 (2024) |
| Lumenis Be, Ltd. Present in Europe in other categories | Israel | Stellar™ SapphireCool™ LG 8x15 Kit | registered |
The 100 most active manufacturers are shown, out of 244.
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- Parent category : Bioimaging and radiotherapy instruments589 manufacturers