BEUDAMED
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    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

    Chongqing COE Display Technology Co., Ltd .

    Manufacturer
    🇨🇳 China

    YANTAI ATOMY DEO TECH DAILY-USE COMMODITY CO., LTD.

    FDA registration
    YANTAI ATOMY DEO TECH DAILY-USE COMMODITY CO., LTD.·1 product·🇨🇳 China

    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

    K-LINK OPTICAL TECHNOLOGY CO., LTD.

    Manufacturer
    🇨🇳 China

    Suzhou Hualun Medical Appliance Co.,Ltd.

    Manufacturer
    🇨🇳 China·1 Importer

    HANGZHOU KELANG TRADING CO., LTD

    Manufacturer
    🇨🇳 China·2 Basic UDI-DIs·2 Devices

    WENZHOU ART & CREATION CO.,LTD

    Manufacturer
    🇨🇳 China

    Wenzhou Yabao Optical Co.,Ltd

    Manufacturer
    🇨🇳 China

    Ruian Dongsheng Trade Co., Ltd

    Manufacturer
    🇨🇳 China

    Wenzhou Olive Optical CO.LTD

    Manufacturer
    🇨🇳 China·1 Importer

    EVERIFE INTERNATIONAL LIMITED

    Manufacturer
    🇨🇳 China

    WENZHOU HIVISION EYEWEAR CO.,LTD

    Manufacturer
    🇨🇳 China·2 Importers

    WENZHOU ROX EYEWEAR CO.,LTD.

    Manufacturer
    🇨🇳 China

    ZHEJIANG EAST OPTICAL TECHNOLOGY CO., LTD.

    Manufacturer
    🇨🇳 China

    WENZHOU ART & CREATION OPTICAL CO.,LTD

    Manufacturer
    🇨🇳 China