# K932673: Apex SPX Cardial

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Feb 18, 1994 after 261 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
- Sep 12, 2025 · Class II · Z-0292-2026: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could 

Source page: https://510kreport.com/device/K932673
Methodology: https://510kreport.com/methodology