# K253686: True Definition DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Japan Corporation
- Decided: Mar 23, 2026 after 122 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K013561 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213999: Deep Learning Image Reconstruction, Ge Medical Systems, LLC (2022) Summary page 5.

## Indications for use
True Definition DL is a deep learning based CT reconstruction method intended for high contrast spatial resolution enhancement for bone and lung imaging. True Definition DL may be used for patients of all ages.

Source page: https://510kreport.com/device/K253686
Methodology: https://510kreport.com/methodology