# K953250: Senographe Pearl and Senographe Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 26, 1996 after 198 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 6, 2004 · Not classified · Z-0284-04: 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
- Feb 6, 2004 · Not classified · Z-0285-04: 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/K953250
Methodology: https://510kreport.com/methodology