BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Varian Medical Systems Imaging Laboratory GmbH

    Reg #: 3003094912 · FEI: 3003094912 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Varian Medical Systems Imaging Laboratory GmbH
    Registration Number
    3003094912
    FEI Number
    3003094912
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Taefernstrasse 7
    City
    Daettwil, Argovia Aargau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K213927

    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
    Phantom, Anthropomorphic, Radiographic IXG
    Accelerator, Linear, Medical IYE
    System, Planning, Radiation Therapy Treatment MUJ
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    Respiratory Gating for Scanners Mobius Verification Phantom Varian SRS E2E Phantom DoseLab Phantom Set ARIA Radiation Therapy Management (v18) Respiratory Gating for Scanners (2.1) PortalVision Advanced Imaging ARIA Radiation Therapy Management System v18.1 ARIA Radiation Therapy Management (v16.1 MR3) Eclipse Treatment Planning System (v18) DoseLab Pro Eclipse Treatment Planning System v18.1 FractionLab DoseLab TG-142 MaximQA Eclipse Treatment Planning System Respiratory Gating for Scanners (RGSC) Gating Reflector Block Eclipse Treatment Planning System v16 Ethos Treatment Management v 2.1 Ethos Treatment Planning v 1.1 Mobius3D ARIA Radiation Therapy Management Eclipse Treatment Planning System v 15.6 Ethos Treatment Management 3, Ethos Treatment Planning 2 On-Board Imager Device Halcyon Ethos Radiotherapy System Mobius3D (4.1)

    Establishment Types

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