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510(k) Data Aggregation

    K Number
    K022810
    Device Name
    COBRASCAN CR-1 FILMLESS
    Date Cleared
    2002-10-11

    (49 days)

    Product Code
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOGRAPHIC DIGITAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.
    Device Description
    The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer.
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    K Number
    K002911
    Device Name
    XSCAN32 TELERADIOLOGY SOFTWARE
    Date Cleared
    2001-06-07

    (262 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOGRAPHIC DIGITAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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