# K162268: Senographe Pristina

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 3, 2016 after 83 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953974 (1996). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990066: CCD Camera, Model 9000, Camtronics, Ltd. (1999) Summary page 4.

## Most influential descendants
- K211725: Senographe Pristina (2021), 1 descendant of its own
- K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (2026), 0 descendants of its own
- K163302: Senographe Pristina (2017), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-0875-2026: Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
- Dec 26, 2023 · Class II · Z-0862-2024: X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
- May 16, 2019 · Class II · Z-2131-2019: Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

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

Source page: https://510kreport.com/device/K162268
Methodology: https://510kreport.com/methodology