# K253678: MAMMOMAT B.brilliant (11372950)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 18, 2026 after 209 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941191 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233539: MAMMOMAT B.brilliant, Siemens Medical Solutions USA, Inc. (2024) Summary page 6.

## Indications for use
The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

Source page: https://510kreport.com/device/K253678
Methodology: https://510kreport.com/methodology