# K203448: uCT ATLAS with uWS-CT-Dual Energy Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Aug 11, 2021 after 261 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (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.
6 later devices descend from it; 3 cite it directly.
0 of 18 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
- 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
- K231482: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis (2023), 1 descendant of its own
- K253173: uCT 780 with uWS-CT-Dual Energy Analysis (2026), 0 descendants of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3282-2026: 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-3281-2026: 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-0221-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

## Indications for use
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc. uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. uWS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

Source page: https://510kreport.com/device/K203448
Methodology: https://510kreport.com/methodology