# K952674: Transact:  Attenuation Correction System for the Apex Cardial Gamma Camera

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Sep 26, 1995 after 106 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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.
125 later devices descend from it; 2 cite it directly.
10 of 126 devices 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.

## Most influential descendants
- K980959: Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera (1998), 123 descendants of its own
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera (1999), 120 descendants of its own
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own

## Recalls of this device
- Sep 12, 2025 · Class II · Z-0290-2026: 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/K952674
Methodology: https://510kreport.com/methodology