# K914807: Apex Helix - a

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Feb 27, 1992 after 125 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has 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
- K080124: Ventri 1.1 (2008), 2 descendants of its own
- K212004: MyoSPECT, MyoSpect ES (2021), 0 descendants of its own
- K083504: GE Discovery NM/CT 570C (2008), 0 descendants of its own

## Recalls of this device
- Jun 13, 2013 · Class I · Z-1789-2013: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Source page: https://510kreport.com/device/K914807
Methodology: https://510kreport.com/methodology