BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthineers AG Varian Cancer Therapy (CTH)

    Reg #: 3006894636 · FEI: 3006894636 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    Siemens Healthineers AG Varian Cancer Therapy (CTH)
    Registration Number
    3006894636
    FEI Number
    3006894636
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Doris-Ruppenstein-Str. 4
    City
    Erlangen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K132935

    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
    Correspondent
    Ali - Rezaei

    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
    Accelerator, Linear, Medical IYE
    Radiological Image Processing Software For Ablation Therapy Planning And Evaluation QTZ
    Couch, Radiation Therapy, Powered JAI
    System, Planning, Radiation Therapy Treatment MUJ
    System, X-Ray, Tomography, Computed JAK
    System, Image Processing, Radiological LLZ
    Block, Beam-Shaping, Radiation Therapy IXI

    Proprietary Names

    syngo RT Therapist Workspace, v4.3.1 & optional 3rd party OIS Connectivity System ARTISTE; ARTISTE Solution ONCOR / PRIMUS Linac with ARIA OIS update myAblation Guide (VC10A) 550 TXT TREATMENT TABLE syngo Dosimetrist V2.7 myAblation Guide (Version VB80A) ONCOR Avant Garde; ONCOR FAMILY; PRIMUS FAMILY ONCOR Expression ONCOR 160 MLC ARTISTE Solution V4.3; ARTISTE Solution with SYS_VC10 COHERENCE RTT Connect; syngo RTT Connect syngo.via RT Image Suite VC10 syngo.CT Clinical Extensions ARTISTE Solution, Sys_VC10C Phase 2 update, with the syngo RT Therapist and RT Oncologist Workspaces, v4.3.1_MR1 KONRAD TREATMENT PLANNING SOFTWARE PRIMUS ARTISTE Solution with SYS_VB50; ARTISTE Solution, V4.2 ZXT RADIATION THER SYNGO RT INTERFACE 3D MLC; MICROMLC; MODULEAF; OPTIFOCUS; SIEMENS IMFAST syngo VSim

    Establishment Types

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