Shanghai United Imaging Healthcare Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
21
510(k) Clearances
80
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1353-2023Class IIShanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed TomograMarch 1, 2023
Z-0087-2023Class IIPositron Emission Tomography and Computed Tomography System, Model: uMI 550May 30, 2022
Z-2594-2021Class IIuEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionaAugust 2, 2021
Z-2593-2021Class IIuMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assAugust 2, 2021
Z-1160-2021Class IIDigitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - ProduJanuary 25, 2021
Z-0445-2021Class IIComputed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntenAugust 5, 2020
Z-0447-2021Class IIComputed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntenAugust 5, 2020
Z-0446-2021Class IIComputed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntenAugust 5, 2020
Z-0448-2021Class IIPositron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 069715768August 5, 2020
Z-2799-2020Class IIuEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated bJuly 16, 2020
Z-2800-2020Class IIuMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by July 16, 2020
Z-2705-2020Class IIComputed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product UsageJune 20, 2020
Z-2703-2020Class IIComputed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product UsageJune 20, 2020
Z-2704-2020Class IIComputed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product UsageJune 20, 2020
Z-2641-2020Class IIComputed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT CompMay 23, 2020
Z-2472-2020Class IIuCT 530 Computed Tomography X-Ray SystemMay 8, 2020
Z-2522-2020Class IIuCT 760 System, Computed Tomography X-ray SystemMay 8, 2020
Z-2819-2020Class IIPositron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 880000March 26, 2020
Z-2521-2020Class IIuDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ traiFebruary 27, 2020
Z-1708-2020Class IIPositron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R0August 26, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uFebruary 13, 2026
K253173uCT 780 with uWS-CT-Dual Energy AnalysisJanuary 20, 2026
K252000uDR Arria & uDR ArisNovember 26, 2025
K252371uMR 680September 25, 2025
K250045uWS-Angio ProSeptember 24, 2025
K251167uDR Aurora CXSeptember 19, 2025
K250040uWS-AngioSeptember 12, 2025
K250246uMR JupiterAugust 5, 2025
K243547uMR UltraJuly 17, 2025
K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)July 17, 2025
K243397uMR 680July 16, 2025
K243666uOmniscanJune 17, 2025
K243122uMR OmegaMay 21, 2025
K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisMay 16, 2025
K242624Medical Image Post-processing Software (uOmnispace.CT)May 14, 2025
K243632uWS-Angio BasicMay 12, 2025
K243376uAngio AVIVA CXApril 28, 2025
K241166uCT 550January 14, 2025
K241079uCT 780January 7, 2025
K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)December 12, 2024