BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EchoInsight

    Reg #: 3008840981 · FEI: 3008840981 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EPSILON IMAGING, INC.
    Registration Number
    3008840981
    FEI Number
    3008840981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333 Jackson Plaza Suite 100
    City
    Ann Arbor
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110447

    Owner / Operator

    Firm Name
    Ultrasound Medical Devices, Inc. (dba Epsilon Imaging Inc.)
    Operator Number
    10034861
    Address
    333 JACKSON PLAZA, Suite 100
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Eric Sieczka

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    EchoInsight

    Establishment Types

    Manufacture Medical Device