BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    V5med Lung AI

    K Number: K242919 · Decision Mar 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    184

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    V5med Lung AI
    K Number
    K242919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    V5med, Inc.
    Date Received
    September 24, 2024
    Decision Date
    March 27, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OEB), ordered by most recent decision date.

    Synapse Lung Nodule AI

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVIEW Lung Nodule CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    InferRead Lung CT.AI

    FDA 510(k)
    FDA Class 2 ·Radiology

    syngo.CT Lung CAD (Version VD30)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVIEW Lung Nodule CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    ClearRead CT

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all