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510(k) Data Aggregation

    K Number
    K992603
    Date Cleared
    1999-10-25

    (83 days)

    Product Code
    Regulation Number
    892.1650
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XRT 600 R/F, WRF 0600

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

    The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

    Device Description

    The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

    AI/ML Overview

    The provided text is a 510(k) K992603 clearance letter for the Wuestec XRT 600 R/F device, along with its "Indications For Use" statement.

    This documentation does not contain any information regarding acceptance criteria, device performance metrics, or study design details. It is a regulatory approval document that states the device has been found substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input.

    To answer your request, I would need a document such as:

    • A premarket submission summary.
    • A clinical study report.
    • A scientific publication detailing the device's performance evaluation.

    The current document only confirms the FDA's regulatory clearance for the device, not the technical or clinical performance data.

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