BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Lunit INSIGHT CXR Triage

    K Number: K211733 · Decision Nov 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    159

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    Basic Information

    Device Name
    Lunit INSIGHT CXR Triage
    K Number
    K211733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lunit, Inc.
    Date Received
    June 4, 2021
    Decision Date
    November 10, 2021
    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 Lunit, Inc.

    K Number Device Name
    K260320 Lunit INSIGHT MMG (v1.1.10)
    K253796 Lunit INSIGHT DBT (V1.2)
    K242652 Lunit INSIGHT DBT v1.1
    K231470 Lunit INSIGHT DBT
    K211678 Lunit INSIGHT MMG