BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ULTRASPECT USA, LLC

    Reg #: 3018788582 · FEI: 3018788582 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ULTRASPECT USA, LLC
    Registration Number
    3018788582
    FEI Number
    3018788582
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 Dillion Court
    City
    Gray
    State
    TN
    ZIP
    37615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030870

    Owner / Operator

    Firm Name
    UltraSPECT USA, LLC
    Operator Number
    10081545
    Address
    101 Dillion Court
    City
    Gray
    State
    TN
    Postal Code
    37615
    Country
    US
    Correspondent
    Michelle Kyker

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Xpress.Bone Xpress.PET Xact.Bone Xpress.Cardiac including ACSC Xpress3.Cardiac including ASCS Xpress3.Cardiac Xact.Parathyroid Xpress.Cardiac UltraSPECT.gate Xact.Cardiac

    Establishment Types

    Manufacture Medical Device