# K213999: Deep Learning Image Reconstruction

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Feb 18, 2022 after 59 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: 9 generations back to K013561 (2001). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183202: Deep Learning Image Reconstruction, Ge Medical Systems, LLC (2019) Summary page 5.

## Most influential descendants
- K253686: True Definition DL (2026), 0 descendants of its own
- K230807: Deep Learning Image Reconstruction (2023), 0 descendants of its own

## Indications for use
The Deep Learning Image Reconstruction option is a deep learning based reconstruction method intended to produce cross-sectional images of the head and whole body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions, for all ages. Deep Learning Image Reconstruction can be used for head, whole body, cardiac, and vascular CT applications.

Source page: https://510kreport.com/device/K213999
Methodology: https://510kreport.com/methodology