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510(k) Data Aggregation

    K Number
    K200282

    Validate with FDA (Live)

    Device Name
    Orfit Aerial Couchtop
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2020-04-08

    (64 days)

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

    The Aerial Couchtop for proton therapy is intended to support, position and immobilize patients during proton radiotherapy treatments.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document describes a 510(k) clearance letter for a medical device called "Orfit Aerial Couchtop," which is a couchtop for proton therapy. It does not contain any information regarding acceptance criteria, device performance, clinical study details, or AI/algorithm performance. Therefore, I cannot generate the requested response.

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