BEUDAMED
    FDA Registration Active 🇫🇷 France

    OptimMRI

    Reg #: 3030088963 · FEI: 3030088963 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    REBRAIN
    Registration Number
    3030088963
    FEI Number
    3030088963
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PTIB, Hopital Xavier Arnozan, Avenue du Haut Leveque
    City
    PESSAC Gironde
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K242054

    Owner / Operator

    Firm Name
    REBRAIN
    Operator Number
    10089358
    Address
    PTIB, Hopital Xavier Arnozan, Avenue du Haut Leveque
    City
    PESSAC
    State
    Gironde
    Postal Code
    33600
    Country
    FR
    Correspondent
    Thomas QUEUCHE

    US Agent

    Business Name
    Puget Ultrasound, Inc
    Contact Name
    Bharat BEDI
    Address
    2425 Squak Mountain loop SW
    City
    Issaquah
    State
    WA
    ZIP
    98027
    Country
    US
    Email
    [email protected]
    Phone
    425 9858670

    Products

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

    Proprietary Names

    OptimMRI

    Establishment Types

    Manufacture Medical Device