# K953801: Varicam

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Nov 22, 1995 after 103 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
8 of 26 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
- K022960: GE Quasar Nuclear Medicine System (2002), 23 descendants of its own
- K093514: Discovery Model NM/CT 670 (2009), 13 descendants of its own
- K153402: Discovery NM/CT 670 CZT (2016), 6 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K102231: Discovery NM 750B (2010), 3 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class II · Z-2098-2025: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in l
- Dec 18, 2024 · Class II · Z-0900-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an
- Oct 30, 2017 · Class II · Z-0704-2019: A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because o
- Oct 30, 2017 · Class II · Z-0703-2019: A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because o
- Mar 5, 2015 · Class II · Z-1279-2015: GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been
- Jun 13, 2013 · Class I · Z-1788-2013: 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.
- Sep 3, 2004 · Not classified · Z-0012-05: GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions 

Source page: https://510kreport.com/device/K953801
Methodology: https://510kreport.com/methodology