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

    AVIEW Lung Nodule CAD

    K Number: K251203 · Decision Dec 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    12
    Review Days
    229

    Basic Information

    Device Name
    AVIEW Lung Nodule CAD
    K Number
    K251203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coreline Soft Co., Ltd.
    Date Received
    April 18, 2025
    Decision Date
    December 3, 2025
    Product Code
    OEB
    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
    OEB Lung Computed Tomography System, Computer-Aided Detection

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    Other Clearances by Coreline Soft Co., Ltd.

    K Number Device Name
    K243689 AVIEW
    K243696 AVIEW CAC
    K233211 AVIEW CAC
    K221592 AVIEW Lung Nodule CAD
    K214036 AVIEW
    K220408 AVIEW RT ACS
    K201710 A View LCS
    K200714 AVIEW
    K193220 AVIEW LCS
    K192040 AVIEW Modeler
    Search all 12 clearances from Coreline Soft Co., Ltd. →