BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMACOR, Inc

    Reg #: 3006382185 · FEI: 3006382185 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    IMACOR, Inc
    Registration Number
    3006382185
    FEI Number
    3006382185
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Jericho Turnpike, Suite 105
    City
    Jericho
    State
    NY
    ZIP
    11753
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080223

    Owner / Operator

    Firm Name
    ImaCor Inc
    Operator Number
    10023490
    Address
    50 Jericho Turnpike, Suite 105
    City
    Jericho
    State
    NY
    Postal Code
    11753
    Country
    US
    Correspondent
    Richard C Lanzillotto

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Echocardiograph DXK
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Zura ImaCor Zura Inaging System ImaCor Zura TEE system ImaCor Zura Handheld Zura system ClariTEE probe

    Establishment Types

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