BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Fibresolve (with PCCP)

    K Number: K252041 · Decision Nov 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    130

    Basic Information

    Device Name
    Fibresolve (with PCCP)
    K Number
    K252041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2085
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imvaria, Inc.
    Date Received
    June 30, 2025
    Decision Date
    November 7, 2025
    Product Code
    QWO
    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
    QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

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    Other Clearances by Imvaria, Inc.

    K Number Device Name
    K241891 ScreenDx
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