# P990066: GE Healthcare Senographe Full Field Digital Mammography System

- Pathway: PMA
- Applicant: GE Healthcare
- Decided: Jan 28, 2000 after 91 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K103485: Senograph DS, Senograph Essenstial (2011), 11 descendants of its own
- 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
- K110798: Senographe DS, Senographe Essential (2011), 3 descendants of its own

## Recalls of this device
- Oct 17, 2011 · Not classified · Z-1063-2012: GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact pat
- Sep 22, 2011 · Not classified · Z-0115-2012: GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may 
- Sep 22, 2011 · Not classified · Z-0114-2012: GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may 
- Feb 6, 2004 · Not classified · Z-0282-04: The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum li

Source page: https://510kreport.com/device/P990066
Methodology: https://510kreport.com/methodology