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510(k) Data Aggregation

    K Number
    K083645
    Device Name
    RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
    Manufacturer
    5 STAR MEDICAL, INC.
    Date Cleared
    2009-02-24

    (77 days)

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

    5 STAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
    Device Description
    The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for viewing the captured images on a Windows-based computer. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings.
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