BEUDAMED
    FDA Registration Active 🇺🇸 United States

    POLAREAN, INC.

    Reg #: 3010132318 · FEI: 3010132318 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    POLAREAN, INC.
    Registration Number
    3010132318
    FEI Number
    3010132318
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2500 Meridian Pkwy, #175
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212239

    Owner / Operator

    Firm Name
    Polarean, Inc.
    Operator Number
    10087679
    Address
    2500 Meridian Pkwy, #175
    City
    Durham
    State
    NC
    Postal Code
    27713
    Country
    US
    Correspondent
    Amanda Morris

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Image Processing, Radiological LLZ

    Proprietary Names

    XENOVIEW 3T Chest Coil Xenoview VDP

    Establishment Types

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