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510(k) Data Aggregation

    K Number
    K990383
    Device Name
    APOLLO 5, APOLLO 10
    Manufacturer
    PRECITRON A.B.
    Date Cleared
    1999-05-05

    (86 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are used to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Apollo 5 and Apollo 10 In-Vivo Dosimetry systems. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

    However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for that specific information based on the provided text. The letter only approves the devices for marketing and states their indications for use.

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