BEUDAMED
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    Chongqing COE Display Technology Co., Ltd .

    Manufacturer
    🇨🇳 China

    Meiliguang (MLG) Medical Instrument (Shenzhen) Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Importer

    SHENZHEN NOE OPTICAL CO., LTD

    FDA registration
    SHENZHEN NOE OPTICAL CO., LTD·2 products·🇨🇳 China

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    FDA Enforcement
    Class II ·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025

    NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Neusoft Medical Systems Co., Ltd.·May 29, 2019

    NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Neusoft Medical Systems Co., Ltd.·May 29, 2019

    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

    FDA Enforcement
    Class II ·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024

    NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Neusoft Medical Systems Co., Ltd.·May 29, 2019

    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024