BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Esaote North America, Inc

    Reg #: 1826555 · FEI: 1826555 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Esaote North America, Inc
    Registration Number
    1826555
    FEI Number
    1826555
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11907 Exit Five Parkway
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190989

    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

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Automated Radiological Image Processing Software QIH
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    6400 Model MyLabX7 MyLabX6 MyLabC25 MyLabC30 ML5 MyLabSeven 7400 MyLabAlpha 6400 MylabGamma 7410 MyLab 9 eXP 6440 Ultrasound System MyLab 9 MyLabX9 6430 US System MyLabX75 MyLab40 Ultrasound System MyLabOmega 7400 model MyLabOmega eXP 7348 MRI Dynamic Analysis Plus MyLabA70 MyLabA50 6450 Model MyLabX8 eXP MyLabX8 Magnifico Open MYLABALPHA MYLABSEVEN Magnifico MSK MyLabE80 MyLabE85 MyLabClass C 6250 MyLabTwice 6200 MyLabEight MyLabEight eXP 7410 model MyLabSigma MyLabSigma elite OrthoCAD G-scan Brio Shoulder Coil 20 S-scan Head Coil 16 S-Scan Open MyLabX90 MyLabSix CrystaLine 6425 ML30 (7300 & 7340) MyLabX5 6420 MyLabSix S-scan Open O-scan G-Scan Brio G-Scan Open AU6 6250 Ultrasound System 6200 Ultrasound System O-Scan Smart O-Scan 3Viseon Speedup Software Option MyLabOne

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198