BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Terarecon, Inc.

    Reg #: 3014146081 · FEI: 3014146081 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Terarecon, Inc.
    Registration Number
    3014146081
    FEI Number
    3014146081
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4309 Emperor Blvd., Suite 310
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011142

    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
    Automated Radiological Image Processing Software QIH
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Intuition Aquarius Workstation TearRecon AV TeraRecon Detect Viewer Intuition-TDA, TVA, Parametric Mapping TeraRecon Neuro TeraRecon Aorta.CT TeraRecon Cardiovascular.Calcification.CT Eureka AI Interoperability Platform Eureka Clinical AI TeraRecon AI Framework Intuition Server Intuition-Structural Heart Module Intuition-T1 Mapping and T2/T2* Mapping TeraRecon Cardiac.Chambers.MR AquariusAPS Server Eureka AI Results Explorer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device