MUE
- Product code
- MUE
- Device name
- Full Field Digital, System, X-Ray, Mammographic
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1715
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 55 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253678 | 2026-06-18 | Siemens Medical Solutions USA, Inc. | MAMMOMAT B.brilliant (11372950) | FDA |
| K254092 | 2026-05-28 | Vieworks Co., Ltd. | Bellalun 2D (VDMS-1000S) | |
| K260087 | 2026-03-24 | GE Medical Systems SCS | Senographe Pristina; SenoBright HD; Pristina Serena;… | |
| K243420 | 2025-07-17 | Genoray Co., Ltd. | HESTIA | |
| K243849 | 2025-03-12 | Rayence Co., Ltd. | 2430TCA with Xmaru W | |
| K241113 | 2025-01-16 | Vieworks Co., Ltd. | VIVIX-M | |
| K233539 | 2024-03-27 | Siemens Medical Solutions USA, Inc. | MAMMOMAT B.brilliant |
Official FDA classification page: MUE
Classification and pathway per current FDA publications. Data from openFDA (CC0).