# K211725: Senographe Pristina

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 6, 2021 after 63 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: 3 generations back to K953974 (1996). 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)
- K162268: Senographe Pristina, GE Healthcare (2016) Summary page 4.

## Most influential descendants
- K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (2026), 0 descendants of its own

## Indications for use
The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

Source page: https://510kreport.com/device/K211725
Methodology: https://510kreport.com/methodology