# K223212: Precision DL

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 27, 2023 after 192 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K010641 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221932: Omni Legend, GE Healthcare (2022) Summary page 5.

## Indications for use
Precision DL is a deep learning-based image processing method intended to enhance image quality of non-ToF PET images for clinical oncology purpose, using F-18 FDG. Precision DL may be used for patients of all ages.

Source page: https://510kreport.com/device/K223212
Methodology: https://510kreport.com/methodology