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Bioimaging and radiotherapy instrumentsDigital bioimaging management instrumentsVarious digital bioimaging management instruments

Various digital bioimaging management instruments - software accessories

EMDN code Z11069082

20 manufacturers, 43 models including 42 on the market, 11 countries

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Manufacturers registered in Europe (EUDAMED) 20
  • 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.
ManufacturerCountryRegistered modelsClassContact
Philips FDA Netherlands
2 others
 IIa, IIb MDR, 93/42 eudamed@philips.com EUDAMED record Report an error
Brainlab FDA Germany I, IIa MDR regulatory.affairs@brainlab.com EUDAMED record Report an error
Deeptracetech Italy I, IIa MDR, 93/42 Website admin@deeptracetech.com EUDAMED record Report an error
Barco FDA Belgium IIa MDR Website EUDAMED record Report an error
EIZO FDA EU representative : EIZO GmbH (Germany) Germany, Japan I, IIa MDR Website EUDAMED record Report an error
Nobel Biocare FDA Sweden I, IIb MDR info.switzerland@nobelbiocare.com EUDAMED record Report an error
Intrasense France IIa MDR Website contact@intrasense.fr EUDAMED record Report an error
Aidence Netherlands I MDR Website PRRC@aidence.com EUDAMED record Report an error
IB Lab FDA Austria I, IIa MDR Website mail@imagebiopsy.com EUDAMED record Report an error
Zetta25 EU representative : DS REP B.V. (Netherlands) Switzerland IIa MDR Website contact@dentsplysirona.com EUDAMED record Report an error
AIRAmed FDA Germany IIa MDR Website info@airamed.de EUDAMED record Report an error
Augmedit FDA Netherlands IIb MDR Website info@augmedit.com EUDAMED record Report an error
Esaote FDA Italy I 93/42 qa@esaote.com EUDAMED record Report an error
Fairtility FDA EU representative : MedNet EC-REP GmbH (Germany) Israel I MDR Website info@fairtility.com EUDAMED record Report an error
Jiangsu Jinyuan Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Medex FDA France I 93/42 EUDAMED record Report an error
Medical-Note Italy I MDR Website info@medical-note.com EUDAMED record Report an error
Prodatasrl Italy I MDR Website info@prodatasrl.eu EUDAMED record Report an error
Sirona Dental Systems FDA Germany IIa MDR Website contact@dentsplysirona.com EUDAMED record Report an error
Videomed FDA Italy I MDR 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) 30

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.

ManufacturerCountryBrandsFDA clearance
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 P160009 (2017)
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
QVIEW MEDICAL United States QVCAD System QVCAD System Installation Kit P150043 (2017)
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)
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)
BENCH7 INC. United States SugarBot K250264 (2025)
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)
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)
GLEAMER Present in Europe in other categories France ChestView US K252486 (2026)
Hologic, Inc. Present in Europe in other categories United States ImageChecker CAD 10.0 P970058 (2016)
QURE.AI TECHNOLOGIES PRIVATE LIMITED Present in Europe in other categories India qXR-LN registered
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
AZmed Present in Europe in other categories France – K243831 (2025)
Better Diagnostics AI Corp. United States – K260851 (2026)
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)
Imidex, Inc. United States – K223133 (2023)
Nobel Biocare C/O Medicim NV Belgium – K252086 (2025)
Qure.Ai Technologies India – K251934 (2026)

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