Skip to content
Emdyca

Bioimaging and radiotherapy instrumentsDigital bioimaging management instrumentsVarious digital bioimaging management instruments

Various digital bioimaging management instruments - medical device software

EMDN code Z11069092

74 manufacturers, 169 models including 163 on the market, 20 countries

Export to CSV
Manufacturers registered in Europe (EUDAMED) 74
  • 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
Brainlab FDA Germany
10 others
 I, IIa, IIb MDR, 93/42 regulatory.affairs@brainlab.com EUDAMED record Report an error
Sirona Dental Systems FDA Germany
5 others
 I 93/42 Website contact@dentsplysirona.com EUDAMED record Report an error
IB Lab FDA Austria
5 others
 I, IIa MDR, 93/42 Website mail@imagebiopsy.com EUDAMED record Report an error
Siemens Healthcare FDA Germany
3 others
 IIa, IIb MDR, 93/42 Website contact@siemens-healthineers.com EUDAMED record Report an error
Change Healthcare Canada FDA EU representative : Emergo Europe B.V. (Netherlands) Canada IIa 93/42 EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Italy, Japan I, IIa MDR Website EUDAMED record Report an error
Quibim FDA Spain IIa, IIb MDR Website contact@quibim.com EUDAMED record Report an error
Siemens Healthineers FDA Germany IIb MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
inHEART FDA France I, IIa MDR contact@inheartmedical.com EUDAMED record Report an error
Ire Rayos X Spain I, IIa MDR Website EUDAMED record Report an error
MPTronic France I MDR Website info@mptronic.com EUDAMED record Report an error
Witapp Italy I 93/42 Website EUDAMED record Report an error
Zetta25 EU representative : DS REP B.V. (Netherlands) Switzerland I, IIa MDR Website contact@dentsplysirona.com EUDAMED record Report an error
Aidoc FDA EU representative : Obelis s.a. (Belgium) Israel I, IIa MDR Website regulation@aidoc.com EUDAMED record Report an error
Augmedit FDA Netherlands I, IIb MDR Website info@augmedit.com EUDAMED record Report an error
Deeptek FDA EU representative : Specculo Limited (Malta) India I, IIb MDR regulatory@deeptek.ai EUDAMED record Report an error
GE Medical Systems Israel, Functional Imaging FDA EU representative : GE Medical Systems SCS (France) Israel IIa MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
Imaging Biometrics FDA EU representative : Casus Consulting Limited (Ireland) United States I 93/42 Website info@imagingbiometrics.com EUDAMED record Report an error
Incepto Medical France IIa MDR Website contact@incepto-medical.com EUDAMED record Report an error
iSchemaView FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other United States IIa, IIb MDR, 93/42 EUDAMED record Report an error
SenseCare Smart Health Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Digitec Italy I, IIa MDR Website info@digitecinnovation.com EUDAMED record Report an error
Esaote FDA Italy IIa MDR qa@esaote.com EUDAMED record Report an error
Ge Hualun Medical Systems FDA EU representative : GE Medical Systems SCS (France) China IIa MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
GE Medical Systems SCS FDA France IIa MDR eudamed@gehealthcare.com EUDAMED record Report an error
Ims Giotto FDA Italy I MDR Website EUDAMED record Report an error
Lunit FDA EU representative : Obelis s.a. (Belgium) South Korea IIa MDR ra_rad@lunit.io EUDAMED record Report an error
MED.e.Com FDA France IIa MDR Website qualite@medecom.fr EUDAMED record Report an error
Shanghai EA Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Enovacom France IIa 93/42 Website EUDAMED record Report an error
Aidence Netherlands IIb MDR Website PRRC@aidence.com EUDAMED record Report an error
AIgnostikum Austria IIa MDR Website EUDAMED record Report an error
Belle FDA EU representative : Belle Europe SAS (France) United States I MDR Website EUDAMED record Report an error
Bettermedicine Estonia IIa MDR Website info@bettermedicine.ai EUDAMED record Report an error
Blackford Analysis FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I MDR Website info@blackfordanalysis.com EUDAMED record Report an error
Bonehealth Italy I MDR Website hello@bonehealth.ai EUDAMED record Report an error
Carpl FDA EU representative : Freyr Regulatory GmbH (Germany) United States I MDR EUDAMED record Report an error
Ceevra FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa MDR Website EUDAMED record Report an error
Connecteve EU representative : Javitech Consulting GmbH (Germany) South Korea IIa MDR EUDAMED record Report an error
Coreline Soft FDA EU representative : JaviTech e.K. (Germany) South Korea IIb MDR rat@corelinesoft.com EUDAMED record Report an error
Deeptracetech Italy IIa MDR Website admin@deeptracetech.com EUDAMED record Report an error
DIGITAL imaging Italy IIa MDR Website EUDAMED record Report an error
EBIT FDA Italy IIa MDR Website qa-ebit@esaote.com EUDAMED record Report an error
El.Co Italy IIa MDR EUDAMED record Report an error
Eurochimica Italy I MDR Website info@eurochimica.net EUDAMED record Report an error
Exprivia Italy IIa MDR Website EUDAMED record Report an error
GE Healthcare FDA EU representative : GE Medical Systems SCS (France) United States I MDR eudamed@gehealthcare.com EUDAMED record Report an error
GPI FDA Italy IIa MDR Website EUDAMED record Report an error
Heartflow FDA EU representative : MDSS GmbH (Germany) United States IIb MDR Website EUDAMED record Report an error
Heuron FDA EU representative : KTR Europe GmbH (Germany) South Korea IIa 93/42 EUDAMED record Report an error
Iknowhealth Greece IIa 93/42 Website info@iknowhealth.com EUDAMED record Report an error
Infinitt FDA EU representative : Obelis s.a. (Belgium) South Korea I MDR Website EUDAMED record Report an error
Mach7T FDA EU representative : Emergo Europe B.V. (Netherlands) Canada IIa MDR Website quality@mach7t.com EUDAMED record Report an error
Medex FDA France I 93/42 EUDAMED record Report an error
Medirecord Czechia I MDR Website info@medirecord.cz EUDAMED record Report an error
MegaGen Implant FDA EU representative : MDSS GmbH (Germany) South Korea IIa 93/42 EUDAMED record Report an error
Metaltronica FDA Italy I MDR Website EUDAMED record Report an error
NeoLogica FDA Italy IIa MDR Website info@neologica.it EUDAMED record Report an error
O3 Enterprise FDA Italy IIa MDR Website info@o3enterprise.com EUDAMED record Report an error
Pathomation Belgium – 98/79 Website info@pathomation.com EUDAMED record Report an error
Philips FDA Netherlands IIb MDR eudamed@philips.com EUDAMED record Report an error
Phönix-PACS Germany I, IIb MDR, 93/42 EUDAMED record Report an error
piur imaging FDA Austria IIa MDR Website EUDAMED record Report an error
Prodatasrl Italy IIa 93/42 Website info@prodatasrl.eu EUDAMED record Report an error
Qure FDA EU representative : Advena Limited (Malta) India IIb MDR Website EUDAMED record Report an error
R.A.W Italy IIa MDR Website quality@endo-sight.it EUDAMED record Report an error
ResolutionMD FDA EU representative : AR Experts B.V. (Netherlands) Canada IIa MDR Website regulatory@resolutionmd.com EUDAMED record Report an error
S.M.A.I.O FDA France IIa MDR Website vigilance@smaio.com EUDAMED record Report an error
Shl Austria IIb MDR Website info@shl.at EUDAMED record Report an error
STARC medical Germany IIa MDR Website info@starc-medical.de EUDAMED record Report an error
Temera Germany I MDR Website info@temera.de EUDAMED record Report an error
Visiana FDA Denmark I 93/42 Website info@visiana.com EUDAMED record Report an error
VUNO FDA EU representative : Obelis s.a. (Belgium) South Korea IIa MDR Website hello@vuno.co EUDAMED record Report an error
Intelligent Ultrasound FDA EU representative : Advena Limited (Malta) No model still on the market United Kingdom (ex Northern Ireland) IIa 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) 14

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
Screenpoint Medical B.V. Present in Europe in other categories Netherlands Transpara K260898 (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)
Icad, Inc. United States ProFound AI V3.0 ProFound AI ProFound Detection K240417 (2024)
Therapixel Present in Europe in other categories France MammoScreen K260714 (2026)
Bot Image, Inc. United States Bot Image, Inc. registered
SEE-MODE TECHNOLOGIES PTE. LTD. Singapore See-Mode Technologies K260303 (2026)
BeamWorks, Inc. South Korea – K260086 (2026)
Hologic, Inc. Present in Europe in other categories United States – K243341 (2025)
Median Technologies United States – K251474 (2026)
Quantib B.V. Present in Europe in other categories Netherlands – K253682 (2026)
Qure.Ai Technologies Pvt. , Ltd. India – K261517 (2026)
SCANMED, LLC Present in Europe in other categories United States – K212783 (2022)
Taihao Medical, Inc. Present in Europe in other categories Taiwan – K210670 (2021)

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Related categories