# K233698: True Enhance DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Japan Corporation
- Decided: Apr 11, 2024 after 146 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213938: Revolution Ascend, Ge Healthcare Japan Corporation (2022) Summary page 4.

## Indications for use
True Enhance DL is a deep learning-based image processing method trained to estimate monochromatic, 50 keV GSI images. The algorithm is intended to improve the contrast of 120 kVp, single energy images of the body. This device is intended to provide non-quantitative, adjunct information and should not be interpreted without the original 120 kVp image. True Enhance DL may be used for patients of all ages.

Source page: https://510kreport.com/device/K233698
Methodology: https://510kreport.com/methodology