# K080124: Ventri 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Jan 31, 2008 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952674 (1995). 30 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051855: Ventri, Ge Medical Systems F.I. Haifa (2005) Summary page 1.
- K062450: D-Spect Cardiac Scanner System, Spectrum Dynamics, Ltd. (2006) Summary page 1.
- K914807: Apex Helix - a, Elscint, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- Nov 30, 2018 · Class II · Z-2259-2020: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload proce
- Jan 9, 2013 · Class II · Z-1168-2013: GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fing

## Indications for use
The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. Ventri 1.1 is primarily intended for cardiac applications

Source page: https://510kreport.com/device/K080124
Methodology: https://510kreport.com/methodology