# K123520: Mammomat Inspiration Prime

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 11, 2013 after 208 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: 1 generation back to P030010 (2004). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 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
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own
- K253678: MAMMOMAT B.brilliant (11372950) (2026), 0 descendants of its own
- K210955: Kubtec Mozart Supra (XPERT 84) Radiography System (2021), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-0878-2026: 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 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/K123520
Methodology: https://510kreport.com/methodology