BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ESAOTE S.P.A.

    Reg #: 8043485 · FEI: 3002806926 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ESAOTE S.P.A.
    Registration Number
    8043485
    FEI Number
    3002806926
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Multedo di Pegli 2/E
    City
    GENOVA Liguria
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K180592

    Owner / Operator

    Firm Name
    ESAOTE S.P.A.
    Operator Number
    8021005
    Address
    via Enrico Melen 77
    City
    Genoa
    State
    Genova
    Postal Code
    16152
    Country
    IT
    Correspondent
    Esaote - Regulatory

    US Agent

    Business Name
    Esaote North America Inc.
    Contact Name
    Kim Akers
    Address
    11907 Exit 5 Pkwy
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US
    Email
    [email protected]
    Phone
    317 8136013

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    G-Scan Brio G-Scan Open OrthoCAD G-scan Brio Shoulder Coil 20 S-scan Head Coil 16 S-Scan Open Magnifico MSK Magnifico Open MRI Dynamic Analysis Plus O-Scan Smart O-Scan O-scan S-scan Open Speedup Software Option

    Establishment Types

    Manufacture Medical Device