# K181414: uCT 530, uCT 550

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Aug 14, 2018 after 76 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930090 (1993). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 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.

## Most influential descendants
- K200016: uCT 530, uCT 550 (2020), 1 descendant of its own
- K241166: uCT 550 (2025), 0 descendants of its own
- K183143: uCT 520, uCT 528 (2019), 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.
- Aug 5, 2020 · Class II · Z-0445-2021: 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
- Aug 5, 2020 · Class II · Z-0446-2021: 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-2704-2020: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- Jun 20, 2020 · Class II · Z-2705-2020: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- May 23, 2020 · Class II · Z-2641-2020: Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent
- May 8, 2020 · Class II · Z-2472-2020: Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent

## Indications for use
The uCT Computed Tomography X-ray System uCT 530/550 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, vascular).

Source page: https://510kreport.com/device/K181414
Methodology: https://510kreport.com/methodology