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Emdyca

Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsMammography systems

Mammography systems - medical device software

EMDN code Z11030292

11 manufacturers, 15 models including 15 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 11
  • 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
Screenpointmed FDA Netherlands IIa, IIb MDR, 93/42 Website info@screenpointmed.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States IIa MDR EUDAMED record Report an error
MX Healthcare Germany IIb MDR Website info@vara.ai EUDAMED record Report an error
E-COM Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb 93/42 EUDAMED record Report an error
G-Squared FDA Italy IIa MDR Website info@gsquared.it EUDAMED record Report an error
Ims Giotto FDA Italy I MDR Website EUDAMED record Report an error
Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa 93/42 services@united-imaging.com EUDAMED record Report an error
Shanghai United Imaging Intelligence FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Siemens Healthcare FDA Germany IIb MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Therapixel FDA France IIa MDR Website contact@therapixel.com EUDAMED record Report an error
Threepalmsoft FDA EU representative : Wellkang Ltd (Northern Ireland) United States I MDR Website info@threepalmsoft.com 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) 13

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
Lunit, Inc. Present in Europe in other categories South Korea Lunit INSIGHT DBT Lunit INSIGHT MMG K260320 (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)
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)
Median Technologies United States – K251474 (2026)
Quantib B.V. Present in Europe in other categories Netherlands – K253682 (2026)
Quibim S.L. Present in Europe in other categories Spain – K242683 (2025)
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)

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