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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K182237
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Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomogra... 2 04/07/2023 Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 2 10/13/2022 Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professiona... 2 09/29/2021 Shanghai United Imaging Healthcare Co., Ltd.
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to ass... 2 09/29/2021 Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 069715768... 2 11/12/2020 Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 880000... 2 08/18/2020 Shanghai United Imaging Healthcare Co., Ltd.
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by ... 2 08/13/2020 Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R0... 2 04/15/2020 Shanghai United Imaging Healthcare Co., Ltd.
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