# K083504: GE Discovery NM/CT 570C

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Dec 12, 2008 after 16 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
Longest line of descent: 6 generations back to K952674 (1995). 39 ancestors in all.
No later device cites it as a predicate yet.
5 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080124: Ventri 1.1, Ge Medical Systems F.I. Haifa (2008) Summary page 1.
- K061817: Lightspeed 7.1 CT Scanner System, Ge Medical Systems, LLC (2006) Summary page 1.
- K043381: Infinia Lightspeed, Ge Medical Systems F.I. Haifa (2004) Summary page 1.
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.

## Recalls of this device
- May 19, 2017 · Class II · Z-2196-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

## Indications for use
The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion). The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

Source page: https://510kreport.com/device/K083504
Methodology: https://510kreport.com/methodology