# K172404: SenoBright HD

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 30, 2017 after 82 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: 2 generations back to P990066 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103485: Senograph DS, Senograph Essenstial, General Electric Company (2011) Summary page 5.

## Most influential descendants
- K211215: SenoBright HD (2021), 0 descendants of its own

## 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/K172404
Methodology: https://510kreport.com/methodology