Shanghai United Imaging Healthcare Co., Ltd. · Class II · Cleared Jan 20, 2026
| K-number | K253173 |
| Device name | uCT 780 with uWS-CT-Dual Energy Analysis |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. |
| Product code | JAK |
| Device class | Class II |
| Decision date | Jan 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1750 |
The uCT 780 is a computed tomography (CT) x-ray system that produces cross-sectional body images through computer reconstruction of x-ray transmission data. It is indicated for whole-body imaging including head, neck, cardiac, and vascular regions, and for low-dose CT lung cancer screening to detect lung nodules that may represent cancer.
The proposed device adds a mobile configuration with a new high voltage generator (uXG 100) alongside the existing CT140N80X4889 model used in non-mobile configurations. Both generators have 100 kW maximum power and identical kV settings (70, 80, 100, 120, 140 kV). The mobile configuration includes gantry tilt locks and patient table locks, while the PSC (Power Supply Cabinet) has been strengthened with a shock-absorbing base and optimized fixing methods.
Testing performed per ANSI/AAMI ES60601-1:2005+A1:2012+A2:2021 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 61223-3-5:2019 (CT imaging performance), IEC 60601-1-3:2008 (radiation protection), IEC 60601-2-44:2016 (CT x-ray equipment), IEC 60601-1-6:2010 (usability), IEC 62304:2006 (software lifecycle), and IEC 60068 series (vibration/shock testing).
View the full FDA submission: accessdata.fda.gov