# K081496: Optima Pet/CT 560

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 12, 2008 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010641 (2001). 7 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050559: GE Discovery VCT System, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K133657: Discovery Pet/CT 710 (2014), 7 descendants of its own
- K161574: Discovery MI (2016), 5 descendants of its own
- K211846: Discovery MI Gen2 (2021), 3 descendants of its own
- K221932: Omni Legend (2022), 2 descendants of its own
- K113408: Q. Freeze (Motion VUE2) (2012), 1 descendant of its own

## Recalls of this device
- Feb 12, 2019 · Class II · Z-1747-2019: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Feb 12, 2019 · Class II · Z-1745-2019: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- May 19, 2017 · Class II · Z-2190-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- Feb 10, 2016 · Class II · Z-1051-2016: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
- Nov 20, 2013 · Class II · Z-0981-2014: GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
- Mar 26, 2013 · Class II · Z-0024-2014: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 61
- Jul 25, 2011 · Class II · Z-1188-2013: Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly re

## Indications for use
The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.

Source page: https://510kreport.com/device/K081496
Methodology: https://510kreport.com/methodology