# K110572: Mammodiagnost DR

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 23, 2011 after 206 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: 1 generation back to P030010 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Philips MammoDiagnost DR is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoDiagnost DR is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K110572
Methodology: https://510kreport.com/methodology