# K122286: Mammomal Inspiration

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 22, 2013 after 207 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P030010 (2004). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System, Siemens Medical Solution (2004) Summary page 2.

## Most influential descendants
- K151645: MAMMOMAT Fusion (2015), 1 descendant of its own
- K163252: Mammomat Fusion with Stereotactic Biopsy (2017), 0 descendants of its own

## Recalls of this device
- Jan 11, 2017 · Class II · Z-1118-2017: Software error
- Oct 28, 2014 · Class II · Z-0523-2015: It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the 
- Sep 18, 2014 · Class II · Z-0086-2015: The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may n
- Apr 25, 2014 · Class II · Z-1638-2014: There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to f
- Feb 28, 2013 · Class II · Z-1694-2013: Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrect

## Indications for use
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under supervision of medical professionals. Mammographic images can be interpreted by either hardcopy film or softcopy workstation.

Source page: https://510kreport.com/device/K122286
Methodology: https://510kreport.com/methodology