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510(k) Data Aggregation

    K Number
    K232058
    Device Name
    YosemiteView 4343W/YosemiteView 3643W
    Date Cleared
    2023-08-03

    (23 days)

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

    CareRay Digital Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator for transfer of diagnostic images (the x-ray generator and the computer are not part of the submission). The functions of the YosemiteView 4343W/ YosemiteView 3643W are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
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    K Number
    K223687
    Device Name
    X-ray Flat Panel Detectors (EverestView 4343X)
    Date Cleared
    2022-12-30

    (21 days)

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

    CareRay Digital Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator for transfer of diagnostic images. The functions of the EverestView 4343X are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer and it doesn't have functions of image post-processing. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
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    K Number
    K221549
    Device Name
    X-ray Flat Panel Detectors (CareView 1800 RF)
    Date Cleared
    2022-08-01

    (62 days)

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

    CareRay Digital Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CareView 1800RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    The CareView 1800RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 434 mm × 434 mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The CareView 1800RF detector can be used for dynamic imaging (fluoroscopy).
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