BEUDAMED
    FDA Registration Active 🇺🇸 United States

    O.N. DIAGNOSTICS, LLC

    Reg #: 3010687441 · FEI: 3010687441 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    O.N. DIAGNOSTICS, LLC
    Registration Number
    3010687441
    FEI Number
    3010687441
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1936 University Ave. Suite 280
    City
    Berkeley
    State
    CA
    ZIP
    94704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113725

    Owner / Operator

    Firm Name
    O.N. Diagnostics, LLC
    Operator Number
    10045946
    Address
    1936 University Ave. Suite 280
    City
    Berkeley
    State
    CA
    Postal Code
    94704
    Country
    US
    Correspondent
    Shui Wong

    Products

    Device Name Product Code
    Densitometer, Bone KGI
    System, Image Processing, Radiological LLZ

    Proprietary Names

    VirtuOst Bone Strength Assessment VirtuOst VirtuOst Vertebral Fracture Assessment

    Establishment Types

    Manufacture Medical Device