BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMVARIA

    Reg #: 3033729853 · FEI: 3033729853 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    IMVARIA
    Registration Number
    3033729853
    FEI Number
    3033729853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2930 Domingo Ave #1496
    City
    Berkeley
    State
    CA
    ZIP
    94705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241891

    Owner / Operator

    Firm Name
    IMVARIA
    Operator Number
    10091350
    Address
    2930 Domingo Ave #1496
    City
    Berkeley
    State
    CA
    Postal Code
    94705
    Country
    US
    Correspondent
    Joshua Reicher

    Products

    Device Name Product Code
    Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. QWO

    Proprietary Names

    ScreenDx Fibresolve

    Establishment Types

    Manufacture Medical Device