# K051855: Ventri

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Aug 2, 2005 after 25 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952674 (1995). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
4 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022960: GE Quasar Nuclear Medicine System, Ge Medical Systems F.I. Haifa (2002) Summary page 1.
- K915470: Optima Nuclear Tomography Stystem, General Electric Co. (1992) Summary page 1.
- K962738: Millennium MT and Millennium MG Nuclear Medicine Systems, GE Medical Systems (1996) Summary page 1.

## 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
- Nov 30, 2018 · Class II · Z-2258-2020: 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
- Nov 3, 2008 · Not classified · Z-2219-2009: GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this

## Indications for use
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.

Source page: https://510kreport.com/device/K051855
Methodology: https://510kreport.com/methodology