BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Respiratory Gating for Scanners (RGSC)

    Reg #: 3010123525 · FEI: 3010123525 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Varian Medical Systems Hungary Kft.
    Registration Number
    3010123525
    FEI Number
    3010123525
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Csorsz utca 45
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K151533

    Owner / Operator

    Firm Name
    Varian Medical Systems, Inc
    Operator Number
    2914292
    Address
    3100 Hansen Way, --
    City
    Palo Alto
    State
    CA
    Postal Code
    94304
    Country
    US

    US Agent

    Business Name
    VARIAN MEDICAL SYSTEMS, INC
    Contact Name
    Ali Rezaei
    Address
    3100 Hansen Way
    City
    Palo Alto
    State
    CA
    ZIP
    94304
    Country
    US
    Email
    [email protected]
    Phone
    650 4246545

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Respiratory Gating for Scanners (RGSC)

    Establishment Types

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