K253678
- 510(k) number
- K253678
- Device name
- MAMMOMAT B.brilliant (11372950)
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- MUE — Full Field Digital, System, X-Ray, Mammographic
- Decision date
- 2026-06-18
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253678.pdf
Official FDA record: K253678
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.