# K193073: Deep Recon

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jul 6, 2020 after 245 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172135: uCT Computed Tomography X-ray System, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.
- K183202: Deep Learning Image Reconstruction, Ge Medical Systems, LLC (2019) Summary page 4.

## Indications for use
Deep Recon is a data driven image reconstruction method based on deep learning technology. It is intended to produce cross-sectional images by computer reconstruction of X-ray transmission data taken at different angles planes, including Axial, Helical, and Cardiac acquisition. Deep Recon is designed to generate CT images with lower image noise, and improved low contrast detectability, and it can reduce the dose required for diagnostic CT imaging. Deep Recon can be used for head, chest, abdomen, cardiac and vascular CT applications for adults. Deep Recon is intended to be used with uCT 760 and uCT 780 only.

Source page: https://510kreport.com/device/K193073
Methodology: https://510kreport.com/methodology