# K133657: Discovery Pet/CT 710

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 21, 2014 after 114 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010641 (2001). 8 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081496: Optima Pet/CT 560, Ge Medical Systems, LLC (2008) Summary page 1.

## Most influential descendants
- 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
- K241266: Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (2025), 0 descendants of its own
- K241665: Omni Legend (2024), 0 descendants of its own

## Recalls of this device
- Feb 12, 2019 · Class II · Z-1746-2019: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Feb 12, 2019 · Class II · Z-1750-2019: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- May 24, 2018 · Class II · Z-2579-2018: DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- May 19, 2017 · Class II · Z-2191-2017: 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
GE PET/CT 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 systems 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 in patients of all ages. 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 systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.

Source page: https://510kreport.com/device/K133657
Methodology: https://510kreport.com/methodology