BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Annalise Enterprise CXR Triage Pneumothorax

    K Number: K213941 · Decision Feb 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    Annalise Enterprise CXR Triage Pneumothorax
    K Number
    K213941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Annalise-Ai
    Date Received
    December 16, 2021
    Decision Date
    February 24, 2022
    Product Code
    QFM
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QFM Radiological Computer-Assisted Prioritization Software For Lesions

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    Other Clearances by Annalise-Ai

    K Number Device Name
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