# K211215: SenoBright HD

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jun 22, 2021 after 60 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P990066 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172404: SenoBright HD, GE Healthcare (2017) Summary page 6.

## Recalls of this device
- 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.

## Indications for use
SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright HD application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion.

Source page: https://510kreport.com/device/K211215
Methodology: https://510kreport.com/methodology