# K894931: Sophycamera DSX Rectangular

- Pathway: 510(k) (Traditional)
- Applicant: Sopha Medical Systems, Inc.
- Decided: Oct 27, 1989 after 86 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: 1 (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
- Dec 10, 2025 · Class II · Z-1044-2026: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details sect

Source page: https://510kreport.com/device/K894931
Methodology: https://510kreport.com/methodology