Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Mammography systems
EMDN code Z110302
Manufacturers registered in Europe (EUDAMED) 18
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
1 other |
IIb MDR, 93/42 | services@united-imaging.com EUDAMED record Report an error |
| Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) | Japan |
|
I, IIb MDR, 93/42 | EUDAMED record Report an error |
| Drtech FDA EU representative : DRTECH Europe GmbH (Germany) | South Korea | IIb MDR, 93/42 | Website EUDAMED record Report an error | |
| Genoray FDA EU representative : Obelis s.a. (Belgium) | South Korea | IIb MDR | EUDAMED record Report an error | |
| Metaltronica FDA | Italy |
|
IIb MDR, 93/42 | Website EUDAMED record Report an error |
| Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
5 others
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Bemems EU representative : Obelis s.a. (Belgium) | South Korea | IIb 93/42 | Website EUDAMED record Report an error | |
| GE Medical Systems SCS FDA | France | IIb MDR | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Siemens Healthcare FDA | Germany | IIb MDR, 93/42 | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb 93/42 | EUDAMED record Report an error | |
| Planmed FDA | Finland |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Allengers FDA EU representative : Easy Medical Device CommV (Belgium) | India |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Careray FDA EU representative : Lotus NL B.V. (Netherlands) | China |
|
IIa MDR | support@careray.com EUDAMED record Report an error |
| Hedymed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb 93/42 | Website EUDAMED record Report an error | |
| Medical Technologies EU representative : mdi Europa GmbH (Germany) | Russia |
|
IIb MDR | Website EUDAMED record Report an error |
| Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) | China |
|
IIb 93/42 | EUDAMED record Report an error |
| Umbria Bioengineering Technologies Societa Benefit | Italy | IIa MDR | Website 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) 44
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 |
|---|---|---|---|
| Hologic, Inc. Present in Europe in other categories | United States | Selenia Dimensions Selenia® Dimensions® I-View I -View™ Contrast Enhanced Digital Mammography Dimensions | K254090 (2026) |
| GE Medical Systems Present in Europe in other categories | United States | not applicable Senographe Pristina Pristina Serena Horizontal Breast Spacer | registered |
| Carestream Health, Inc. Present in Europe in other categories | United States | DIRECTVIEW CR Mammography Cassette with EHR-M Screen DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen CARESTREAM CR Mammography Cassette with SNP-M1 Screen DIRECTVIEW CR Mammography Cassette with HR Screen | K120246 (2012) |
| IMS GIOTTO SPA Present in Europe in other categories | Italy | GIOTTO CLASS GIOTTO IMAGE BIOPSY DIGIT MAMMOBED | K200424 (2020) |
| I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | – | GIOTTO IMAGE 3DL | registered |
| Agfa Corp. Present in Europe in other categories | United States | CR HD5.0 AEC CASSETTE DX-M | registered |
| 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) |
| Vieworks Co., Ltd. Present in Europe in other categories | South Korea | VIVIX-M 2430S Bellalun 2D VIVIX-M 1824S | K254092 (2026) |
| Philips Digital Mammography Sweden AB | Sweden | MicroDose SI | K130704 (2013) |
| Rayence Co., Ltd. Present in Europe in other categories | South Korea | 2430MCA 2430TCA | K243849 (2025) |
| Bot Image, Inc. | United States | Bot Image, Inc. | registered |
| IcRco, Inc. | United States | 3600 | K122510 (2013) |
| SEE-MODE TECHNOLOGIES PTE. LTD. | Singapore | See-Mode Technologies | K260303 (2026) |
| Adani | Belarus | – | K172027 (2017) |
| BeamWorks, Inc. | South Korea | – | K260086 (2026) |
| Block Imaging SAS | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| EverX / Bindra | Australia | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GE Healthcare Present in Europe in other categories | United States | – | K211725 (2021) |
| HM Product Solutions, Ltd. | United States | – | registered |
| Konica Minolta, Inc. Present in Europe in other categories | Japan | – | registered |
| Kuehne GmbH | Germany | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Median Technologies | United States | – | K251474 (2026) |
| Medivest Group | United Kingdom | – | registered |
| Metropolis International, LLC | United States | – | registered |
| PROBO Medical SAS | France | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | K110572 (2011) |
| 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) |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Sedecal., Sa. Present in Europe in other categories | United States | – | registered |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K253678 (2026) |
| Taihao Medical, Inc. Present in Europe in other categories | Taiwan | – | K210670 (2021) |
| Tromp Medical | Netherlands | – | registered |
| Vmi Tecnologias Ltda | Brazil | – | K210151 (2022) |
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