# K103485: Senograph DS, Senograph Essenstial

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Company
- Decided: Oct 6, 2011 after 314 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: 1 generation back to P990066 (2000). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P990066: GE Healthcare Senographe Full Field Digital Mammography System, GE Healthcare (2000) Summary page 1.

## Most influential descendants
- K123873: Contrast Enhanced Digital Mammography (2013), 8 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own
- K172404: SenoBright HD (2017), 1 descendant of its own

## Indications for use
Contrast Enhanced Spectral Mammography (CESM) is an extension of the existing indication for diagnostic mammography with the Senographe Essential or Senographe DS. The CESM 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 localize a known or suspected lesion.

Source page: https://510kreport.com/device/K103485
Methodology: https://510kreport.com/methodology