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510(k) Data Aggregation

    K Number
    K201796
    Device Name
    1717SCV, 1717SGV
    Manufacturer
    Rayence Co., Ltd.
    Date Cleared
    2020-07-23

    (23 days)

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

    Rayence Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1717SCV and 1717SGV X-ray detectors, 127um and 140um, are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    1717SCV / 1717SGV is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. 1717SCV and 1717SGV have the same Hardware, Software and components. The type of scintillator layer are different: Cesium Iodide for 1717SCV and Gadolinium Oxsulfide for 1717SGV. Scintillator is a phosphor that produces scintillations. The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection. Also, the subject detectors have an Automatic Exposure Control (AEC) feature. The RAW files can be further processed as DICOM compatible image files by separate console SW (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview)/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis. The software used with the subject detectors is the same as the software XmaruView V1 used with the predicate K190866.
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    K Number
    K162518
    Device Name
    1012WCC, 1012WGC
    Manufacturer
    RAYENCE CO., LTD.
    Date Cleared
    2016-10-06

    (27 days)

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

    RAYENCE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1012WCC and 1012WGC Digital Flat Panel X-Ray Detector are indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). They are intended to replace film based radio 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
    1012WCC / 1012WGC is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as a DICOM compatible image file by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a diagnostic analysis.
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