BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEOCOIL, LLC

    Reg #: 3006369484 · FEI: 3006369484 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    NEOCOIL, LLC
    Registration Number
    3006369484
    FEI Number
    3006369484
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    N27 W23910A PAUL RD.
    City
    Pewaukee
    State
    WI
    ZIP
    53072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222407

    Owner / Operator

    Firm Name
    NeoCoil, LLC
    Operator Number
    9099325
    Address
    N27 W23910A PAUL RD., Suite A
    City
    Pewaukee
    State
    WI
    Postal Code
    53072
    Country
    US

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    3T GE 6-Channel Phased Array Flex Coil 1.5T GE 6-Channel Phased Array Flex Coil 16ch Breast Coils 3T 16ch Breast Coil 1.5T 16ch Breast Coil GE 1.5T 6-Channel Phased Array Wireless Audio System NeoCoil 1.5T GEM Flex Coil 3T 32ch AIR Open Coil Suite 1.5T AIR Open Head Neck Posterior 9ch 3T AIR Open Head Neck Posterior 9ch 1.5T 32ch AIR Open Coil Suite 3T AIR Open Neck Chest Anterior 7ch 3T AIR Open Head Anterior 16ch 1.5T AIR Open Head Anterior 16ch 32Ch AIR Open Coil Suite 1.5T AIR Open Neck Chest Anterior 7ch NEOCOIL 3T 6-CHANN NEOCOIL 3T 6-Ch Carotid Coil NEOCOIL 3T 8-Ch Shoulder Coil 1.5T Flex SPEEDER 3T Flex SPEEDER 3T 16ch Shoulder Coil 1.5T 16ch Shoulder Coil 1.5T Shoulder Coil HD 8ch Shoulder Coil NeoCoil 1.5T 8-Channel Shoulder Array Coil NeoCoil 1.5T 8-ch Shoulder Coil NEOCOIL 1.5T 8-Ch Shoulder Coil GEM Flex MetaFlex Coil GEM Flex Coil, 1.5T GEM Flex Coil 16-M Array, 1.5T Receive Only GEM Flex Interface 16ch Fixed, 1.5T P Connector GEM Flex Coil 16-L Array, 1.5T Receive Only GEM Flex Interface 16ch Fixed, 1.5T HD Connector GEM Flex Coil 16-S Array, 1.5T Receive Only 1.5T GEM Flex Coil Patient Entertainment and Communication System Sentinel, Patient Entertainment and Communication System 1.5T Flex Coil for Siemens NEOCOIL 3T 32-Channel Torso Coil 1.5T 16ch Flex SPEEDER NeoCoil 3T GEM Flex Coil

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device