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510(k) Data Aggregation

    K Number
    K971074
    Device Name
    THERAPAX SXT 150
    Manufacturer
    Date Cleared
    1997-06-13

    (81 days)

    Product Code
    Regulation Number
    892.5900
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THERAPAX SXT 150

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

    The Therapax SXT 150 is a variable low energy x-ray system intended for superficial cases and lesions. Typical applications include radiotherapy treatments of cancerous tumors and research. Typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karpos's Sarcoma, rectal adenocarcinoma and other intracavital sites.

    Device Description

    variable low energy x-ray system

    AI/ML Overview

    This is a letter acknowledging the receipt and review of a 510(k) premarket notification for the "Therapax SXT 150 X-Ray Therapy Device." This document itself does not contain any information about acceptance criteria or a study proving device performance against such criteria. It is a regulatory approval letter based on the device being substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from the given text.

    To address your request, I would need a different document, such as a 510(k) summary, a clinical study report, or a technical specification document that describes the device's performance characteristics and the studies conducted to establish them.

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