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510(k) Data Aggregation

    K Number
    K102237
    Device Name
    PVS MODEL 1.0
    Manufacturer
    MEDCOM GMBH
    Date Cleared
    2010-11-23

    (106 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PVS MODEL 1.0

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

    The PVS patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text focuses on an FDA 510(k) clearance letter for a medical device (PVS 1.0) and its indications for use. It does not contain the specific information required to complete the detailed request about acceptance criteria and a study proving device performance.

    The document confirms the device is substantially equivalent to a predicate device and can be marketed, but it doesn't describe the technical details of acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement in the way the prompt requires.

    Therefore, I cannot provide the requested table and study details based on the given information.

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