# P140011: Mammomat Inspiration with Tomosynthesis Option

- Pathway: PMA
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 21, 2015 after 299 days
- Product code: OTE (Digital Breast Tomosynthesis)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 12, 2016 · Class II · Z-0888-2016: A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to

Source page: https://510kreport.com/device/P140011
Methodology: https://510kreport.com/methodology