BEUDAMED
    FDA Registration Active 🇺🇸 United States

    syngo Ultrasound Breast Analysis (sUSBA)

    Reg #: 3023245 · FEI: 3023245 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Registration Number
    3023245
    FEI Number
    3023245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    22010 S.E. 51ST ST.
    City
    ISSAQUAH
    State
    WA
    ZIP
    98029
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192085

    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, Digital Image Communications, Radiological LMD

    Proprietary Names

    syngo Ultrasound Breast Analysis (sUSBA)

    Establishment Types

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