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    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    BNG Medical Instruments Co., Ltd.

    Manufacturer
    🇨🇳 China

    ARM AND ELBOW PROTECTIONS

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS)

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS)

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    ARM AND ELBOW PROTECTIONS

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    ARM AND ELBOW PROTECTIONS

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    ARM AND ELBOW PROTECTIONS

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Tian Yi Gong Mao You Xian Gong Si·On the market·32 countries

    Dong Hai Xiang Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE

    Device
    EU MDR · Eu Md Class 1 ·DONG GUAN OU KANG ELECTRONICS CO.,LTD·On the market·32 countries

    JETCROWN INDUSTRIAL (DONG GUAN) LTD.

    FDA registration
    JETCROWN INDUSTRIAL (DONG GUAN) LTD.·3 products·🇨🇳 China

    Ezra Innovation (Dong guan) Limited

    FDA registration
    Ezra Innovation (Dong guan) Limited·2 products·🇨🇳 China

    GUANG DONG EDA TECHNOLOGY CO., LTD.

    FDA registration
    GUANG DONG EDA TECHNOLOGY CO., LTD.·6 products·🇨🇳 China

    DONG GUAN TUTAMEN METALWORKS CO, LTD.

    FDA registration
    DONG GUAN TUTAMEN METALWORKS CO, LTD.·10 products·🇨🇳 China

    DONG GUAN DANCHEN ELECTRICAL PRODUCTS LTD.

    FDA registration
    DONG GUAN DANCHEN ELECTRICAL PRODUCTS LTD.·2 products·🇨🇳 China

    DONG GUAN AIJIE OPTICAL CO., LTD

    FDA registration
    DONG GUAN AIJIE OPTICAL CO., LTD·2 products·🇨🇳 China

    DONG GUAN GANG MEI OPTICAL LIMITED

    FDA registration
    DONG GUAN GANG MEI OPTICAL LIMITED·4 products·🇨🇳 China

    VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.

    FDA registration
    VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.·29 products·🇨🇳 China

    DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD

    FDA registration
    DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD·4 products·🇨🇳 China