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Shanghai United Imaging Healthcare Co., Ltd.

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Comput recall (Z-1353-2023)Shanghai United Imaging Healthcare Co., Ltd.2023-04-07
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 recall (Z-0087-2023)Shanghai United Imaging Healthcare Co., Ltd.2022-10-13
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be recall (Z-2799-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-08-13
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be op recall (Z-2800-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-08-13
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Prod recall (Z-2703-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-07-27
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Prod recall (Z-2704-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-07-27
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Prod recall (Z-2705-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-07-27
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uC recall (Z-2641-2020)Shanghai United Imaging Healthcare Co., Ltd.2020-07-20

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Every clearance here is in the API, with alerts when new ones post.