FDA-Device2025-10-29Class II

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

UIH Technologies LLC
Hazard

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Sold states
US: OUS:
Affected count
11 units
Manufactured in
9380 Kirby Dr, Houston, TX, United States
Products
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0219-2026

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