MAMMOMAT B.brilliant (11372950)— 510(k) K253678
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K253678 for MAMMOMAT B.brilliant (11372950), Substantially Equivalent on 2026-06-18. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's MAMMOMAT B.brilliant (11372950) is filed under MUE, full-field digital mammographic x-ray systems. The record doesn't describe the system beyond the model number and the code name.
Class II, 21 CFR 892.1715. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Siemens filed from Malvern, Pennsylvania. The decision came 209 calendar days after receipt (November 21, 2025 to June 18, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code MUE
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.