BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biograph mCT Flow Edge-4R

    Reg #: 1423253 · FEI: 1000514697 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Registration Number
    1423253
    FEI Number
    1000514697
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2501 NORTH BARRINGTON RD.
    City
    Hoffman Estates
    State
    IL
    ZIP
    60192
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151486

    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 mCT Flow Edge-4R Biograph mCT Flow Biograph mCT Flow 40 Biograph mCT Flow 20-3R Biograph mCT X Biograph mCT Flow 40-3R Biograph mCT 20 Excel Biograph mCT S(20)-3R (aka Biograph mCT Excel) Biograph mCT Flow 40-4R Biograph mCT S(64)-3R Biograph mCT S 20 Excel Biograph mCT Flow 20-4R Biograph mCT Flow 64 Biograph mCT Flow 20 Biograph mCT S(40)-4R Biograph mCT S (20)-3R Biograph mCT S(64)-4R Biograph mCT Flow Edge Biograph mCT Flow 64-3R Biograph mCT X-3R Biograph mCT S(40)-3R Biograph mCT S Biograph mCT X-4R Biograph mCT Biograph mCT Flow Edge-3R Biograph mCT Flow 64-4R Biograph mCT S (20)-4R Biograph mCT - VG60

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device