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510(k) Data Aggregation

    K Number
    K123152
    Device Name
    VITESSE 3.0
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Date Cleared
    2012-12-07

    (59 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K103394
    Device Name
    BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Date Cleared
    2011-01-12

    (54 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
    Device Description
    The Barcode Conical Collimator Verification (BCCV) device provides verification of conical collimators for the Varian High Energy Clinac (K100890) and TrueBeam (K092871) devices. Conical collimators are used during stereotactic radiodurgery (SRS) treatments to deliver small diameter treatment beams. The BCCV will prevent treatment until the conical collimator, as required by the treatment plan, has been scanned.
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    K Number
    K101294
    Device Name
    PT2 VARIAN PROTON THERAPY SYSTEM
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Date Cleared
    2010-12-27

    (231 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.
    Device Description
    PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation in accordance with a physician's prescription. The system consists of four major components, 1) Cyclotron required to generate the photon beam 2) Beam line - transports beam from the cyclotron to the required treatment room 3) Up to 4 radiation treatment rooms 4) Treatment Control room
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    K Number
    K101751
    Device Name
    VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
    Manufacturer
    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
    Date Cleared
    2010-08-10

    (49 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).
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