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

    Lunit INSIGHT DBT v1.1

    K Number: K242652 · Decision Oct 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    Lunit INSIGHT DBT v1.1
    K Number
    K242652
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lunit, Inc.
    Date Received
    September 4, 2024
    Decision Date
    October 4, 2024
    Product Code
    QDQ
    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
    QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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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)
    K231470 Lunit INSIGHT DBT
    K211678 Lunit INSIGHT MMG
    K211733 Lunit INSIGHT CXR Triage