# K151645: MAMMOMAT Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 14, 2015 after 88 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P030010 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- P990066: GE Healthcare Senographe Full Field Digital Mammography System, GE Healthcare (2000) Summary page 5.

## Most influential descendants
- K163252: Mammomat Fusion with Stereotactic Biopsy (2017), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-0879-2026: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary

## Indications for use
The Mammomat Fusion system generates digital mammographic images that can be used for screening and diagnosis 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/K151645
Methodology: https://510kreport.com/methodology