BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021

    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Positron Emission Tomography and Computed Tomography System, Model: uMI 550

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025