BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biograph 64 TruePoint

    Reg #: 1034973 · FEI: 1034973 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Registration Number
    1034973
    FEI Number
    1034973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    810 INNOVATION DR.
    City
    KNOXVILLE
    State
    TN
    ZIP
    37932
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060631

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    Biograph 64 TruePoint Biograph TruePoint Biograph 40 TruePoint Biograph 64 TP-4R Biograph 64 TruePoint w/TrueV Biograph 64 TP-3R Biograph 40 TP-3R Biograph 40 TruePoint w/TrueV Biograph 40 TP-4R

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility