# K141477: Discovery IQ

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 18, 2014 after 106 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: 7 generations back to K010641 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133657: Discovery Pet/CT 710, Ge Medical Systems, LLC (2014) Summary page 4.

## Recalls of this device
- Feb 12, 2019 · Class II · Z-1748-2019: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- May 24, 2018 · Class II · Z-2578-2018: Some CT and CT/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-2192-2017: 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 Discovery IQ PET/CT system is 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 system is 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. This device can also assist in radiotherapy planning. The system 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/K141477
Methodology: https://510kreport.com/methodology