# K163252: Mammomat Fusion with Stereotactic Biopsy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 10, 2017 after 53 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: 3 generations back to P030010 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122286: Mammomal Inspiration, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.
- K151645: MAMMOMAT Fusion, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Indications for use
The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.

Source page: https://510kreport.com/device/K163252
Methodology: https://510kreport.com/methodology