# K201745: Deep Learning Image Reconstruction for Gemstone Spectral Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Dec 10, 2020 after 167 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.
No later device cites it as a predicate yet.
0 of 15 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.

## Indications for use
The Deep Learning Image Reconstruction for Gemstone Spectral Imaging option is a deep learning based CT reconstruction method intended to produce cross-sectional images by computer reconstruction of dual energy X-ray transmission data acquired with Gemstone Spectral Imaging, for all ages. Deep Learning Image Reconstruction for Gemstone Spectral Imaging can be used for whole body, vascular, and contrast enhanced head CT applications.

Source page: https://510kreport.com/device/K201745
Methodology: https://510kreport.com/methodology