BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intuition-T1 Mapping and T2/T2* Mapping

    Reg #: 3014146081 · FEI: 3014146081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Terarecon, Inc.
    Registration Number
    3014146081
    FEI Number
    3014146081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4309 Emperor Blvd., Suite 310
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180916

    Owner / Operator

    Firm Name
    TERARECON, INC.
    Operator Number
    9039992
    Address
    4309 Emperor Blvd., Suite 310
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Patrick Willhite

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Intuition-T1 Mapping and T2/T2* Mapping

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device