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510(k) Data Aggregation

    K Number
    K112751
    Device Name
    SDX-4343CS
    Manufacturer
    SAMSUNG MOBILE DISPLAY CO., LTD
    Date Cleared
    2011-11-23

    (63 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMSUNG MOBILE DISPLAY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.
    Device Description
    SDX-4343CS digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343CS is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343CS, digital flat panel X-ray detector.
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    K Number
    K112558
    Device Name
    DIGITAL FLAT PANEL X-RAY DETECTOR
    Manufacturer
    SAMSUNG MOBILE DISPLAY CO., LTD
    Date Cleared
    2011-11-10

    (69 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMSUNG MOBILE DISPLAY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
    Device Description
    SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.
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    K Number
    K102321
    Device Name
    DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
    Manufacturer
    SAMSUNG MOBILE DISPLAY CO., LTD
    Date Cleared
    2011-02-11

    (178 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMSUNG MOBILE DISPLAY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.
    Device Description
    The SDX-4336CP is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4336CP is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW. SDX-4336CP is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic
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    K Number
    K102587
    Device Name
    LLX240AB01
    Manufacturer
    SAMSUNG MOBILE DISPLAY CO., LTD
    Date Cleared
    2010-12-01

    (83 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMSUNG MOBILE DISPLAY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LLX240AB0! digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
    Device Description
    LLX240AB01 is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. LLX240AB01 is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW. LLX240AB01 is a X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can be utilized for digitalizing x-ray images by converting X-ray photons into visible light and then to electronic image data that a computer can read and display for diagnostic purposes.
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    K Number
    K090742
    Device Name
    DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
    Manufacturer
    SAMSUNG MOBILE DISPLAY CO., LTD
    Date Cleared
    2009-09-18

    (182 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMSUNG MOBILE DISPLAY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LTX240AA01-A Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems to in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    LTX240AA01-A is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. LTX240AA01-A is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic
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