# K172135: uCT Computed Tomography X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Mar 2, 2018 after 231 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 10 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 5.

## Most influential descendants
- K203448: uCT ATLAS with uWS-CT-Dual Energy Analysis (2021), 6 descendants of its own
- K181414: uCT 530, uCT 550 (2018), 3 descendants of its own
- K230162: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (2023), 2 descendants of its own
- K223028: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (2023), 2 descendants of its own
- K241079: uCT 780 (2025), 1 descendant of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3279-2026: 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-3280-2026: 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-0219-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Sep 12, 2025 · Class II · Z-0220-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Aug 5, 2020 · Class II · Z-0447-2021: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessar
- Jun 20, 2020 · Class II · Z-2703-2020: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- May 8, 2020 · Class II · Z-2522-2020: Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due 

## Indications for use
uCT 760/780 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 and vascular).

Source page: https://510kreport.com/device/K172135
Methodology: https://510kreport.com/methodology