Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsMammography systems
Mammography systems - hardware accessories
EMDN code Z11030280
Manufacturers registered in Europe (EUDAMED) 4
- 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 |
|---|---|---|---|---|
| Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) | Japan |
|
I MDR | EUDAMED record Report an error |
| GE Medical Systems SCS FDA | France | IIb MDR | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | services@united-imaging.com EUDAMED record Report an error | |
| Planmed FDA No model still on the market | Finland |
|
IIb 93/42 | 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) 35
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 |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | Mammomat Inspiration MAMMOMAT Revelation MAMMOMAT B.brilliant Mammomat Fusion | registered |
| DRTECH Corporation Present in Europe in other categories | South Korea | RoseM AIDIA | K220073 (2023) |
| Vieworks Co., Ltd. Present in Europe in other categories | South Korea | VIVIX-M 2430S Bellalun 2D VIVIX-M 1824S | K254092 (2026) |
| METALTRONICA SPA Present in Europe in other categories | Italy | SERENYS DR HELIANTHUS | K202822 (2021) |
| 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) |
| Genoray Co., Ltd. Present in Europe in other categories | South Korea | Genoray | K243420 (2025) |
| IcRco, Inc. | United States | 3600 | K122510 (2013) |
| Adani | Belarus | – | K172027 (2017) |
| 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 |
| 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) |
| 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) |
| Tromp Medical | Netherlands | – | registered |
| Vmi Tecnologias Ltda | Brazil | – | K210151 (2022) |
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Related categories
- Digital mammography systems18 manufacturers
- Mammography systems - medical device software11 manufacturers
- Conventional mammography systems5 manufacturers
- Mammography systems - software accessories3 manufacturers
- Mammography systems - consumables1 manufacturer
- Parent category : Mammography systems18 manufacturers