A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and func
| Company | Devices | Share |
|---|---|---|
| Hologic, Inc. | 99 | 43% |
| Fujifilm Corporation | 64 | 28% |
| Ge Medical Systems | 39 | 17% |
| Ims Giotto Spa | 11 | 5% |
| Siemens Healthcare Gmbh | 5 | 2% |
| I.M.S. Internazionale Medico Scientifica Srl | 3 | 1% |
| Philips Digital Mammography Sweden Ab | 2 | 1% |
| Metaltronica Spa | 2 | 1% |
| Planmed Oy | 1 | 0% |
| Vieworks Co., Ltd. | 1 | 0% |
| Genoray Co., Ltd. | 1 | 0% |
| Drtech Corporation | 1 | 0% |
Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| MUE | Full field digital,system,x-ray,mammographic | 130 |
| OTE | Digital breast tomosynthesis | 59 |
| MUE | Full field digital, system, x-ray, mammographic | 37 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 21 |
| FMQ | Restraint, protective | 13 |
| OTE | Digital Breast Tomosynthesis | 6 |
Use these as the dimensions to specify in a tender line.
229 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary mammographic x-ray system, digital", from 12 companies. The largest labeler is Hologic, Inc. with 43% of records.
MUE (Full field digital,system,x-ray,mammographic), OTE (Digital breast tomosynthesis), MUE (Full field digital, system, x-ray, mammographic), MUE (Full Field Digital, System, X-Ray, Mammographic)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.