# K212067: Deep Learning Image Reconstruction

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Japan Corporation
- Decided: Sep 17, 2021 after 77 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)
- K193170: Deep Learning Image Reconstruction, Ge Healthcare Japan Corporation (2019) Summary page 4.

## Indications for use
The Deep Learning Image Reconstruction software 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 software can be used for head, whole body, cardiac, and vascular CT applications.

Source page: https://510kreport.com/device/K212067
Methodology: https://510kreport.com/methodology