# K183143: uCT 520, uCT 528

- Pathway: 510(k) (Traditional)
- Applicant: Shangai United Imaging Healthcare Co., Ltd.
- Decided: Jan 3, 2019 after 51 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: 7 generations back to K930090 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181414: uCT 530, uCT 550, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.

## Indications for use
The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Source page: https://510kreport.com/device/K183143
Methodology: https://510kreport.com/methodology