# K200016: uCT 530, uCT 550

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Feb 25, 2020 after 53 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 14 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.
- K172135: uCT Computed Tomography X-ray System, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K241166: uCT 550 (2025), 0 descendants of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3277-2026: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents
- Aug 11, 2026 · Class II · Z-3278-2026: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents
- Sep 12, 2025 · Class II · Z-0217-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Sep 12, 2025 · Class II · Z-0218-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

## Indications for use
The uCT Computed Tomography X-ray System uCT530/550 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, cardiac (calcium scoring) and vascular.

Source page: https://510kreport.com/device/K200016
Methodology: https://510kreport.com/methodology