# K190809: Sample Imaging for Senographe Pristina

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jul 29, 2019 after 122 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: 6 generations back to K941191 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173408: Mammomat Revelation, Siemens Medi Cal Solutions, Inc. (2018) Summary page 5.

## Indications for use
Sample Imaging for Senographe PristinaTM with Pristina SerenaTM biopsy option is intended to provide digital X-ray images of the biopsy excised breast tissues while the patient is still under compression, to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Source page: https://510kreport.com/device/K190809
Methodology: https://510kreport.com/methodology