BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StoneChecker

    Reg #: 3007225492 · FEI: 3007225492 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    IMAGING BIOMETRICS, LLC
    Registration Number
    3007225492
    FEI Number
    3007225492
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13416 Watertown Plank Rd Suite 260
    City
    Elm Grove
    State
    WI
    ZIP
    53122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191530

    Owner / Operator

    Firm Name
    Imaging Biometrics, LLC
    Operator Number
    10025928
    Address
    13416 Watertown Plank Rd, Suite 260
    City
    Elm Grove
    State
    WI
    Postal Code
    53122
    Country
    US
    Correspondent
    Michael J Schmainda

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    StoneChecker

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device