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

    Annalise Enterprise

    K Number: K250831 · Decision Apr 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    Annalise Enterprise
    K Number
    K250831
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Annalise-Ai
    Date Received
    March 19, 2025
    Decision Date
    April 23, 2025
    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
    K213941 Annalise Enterprise CXR Triage Pneumothorax