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510(k) Data Aggregation

    K Number
    K042397
    Device Name
    SCANX 14
    Date Cleared
    2004-10-05

    (33 days)

    Product Code
    Regulation Number
    892.1680
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SCANX 14

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.

    Device Description

    The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "ScanX 14." It states that the device is substantially equivalent to a predicate device for its intended use, which is reading photostimulable phosphor plates and displaying/storing the images.

    Critically, this document is an FDA clearance letter and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the input text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets, data provenance, or training sets.
    3. Number or qualifications of experts.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. How ground truth for training or test sets was established.
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