LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022810
    Device Name
    COBRASCAN CR-1 FILMLESS
    Manufacturer
    RADIOGRAPHIC DIGITAL IMAGING, INC.
    Date Cleared
    2002-10-11

    (49 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K953942
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K953942

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Cobrascan CR-1 Filmless device, a computed radiography dual-technology scanner. It states that the device is substantially equivalent to a legally marketed predicate device.

    However, the document DOES NOT contain information about specific acceptance criteria, study details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods), or performance metrics (like sensitivity, specificity, or reader study results). The letter focuses on regulatory approval based on substantial equivalence rather than detailed clinical or technical performance studies.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1