BEUDAMED
    FDA Registration Active 🇫🇷 France

    inHEART MODELS

    Reg #: 3018302800 · FEI: 3018302800 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INHEART
    Registration Number
    3018302800
    FEI Number
    3018302800
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IHU Liryc - Hopital Xavier Arnozan, Avenue du Haut Leveque
    City
    Pessac Gironde
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K231683

    Owner / Operator

    Firm Name
    inHEART
    Operator Number
    10081210
    Address
    IHU Liryc - Hopital Xavier Arnozan, Avenue du Haut Leveque
    City
    Pessac
    State
    Gironde
    Postal Code
    33600
    Country
    FR

    US Agent

    Business Name
    inHEART Inc
    Contact Name
    David Gareau
    Address
    4000 Eiland Drive
    City
    Sebring
    State
    FL
    ZIP
    33875
    Country
    US
    Email
    [email protected]
    Phone
    609 7131865

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    inHEART MODELS

    Establishment Types

    Manufacture Medical Device