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510(k) Data Aggregation

    K Number
    K060187
    Device Name
    TOPSLANE DMLC
    Date Cleared
    2006-07-27

    (184 days)

    Product Code
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPSLANE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
    Device Description
    TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
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    K Number
    K963451
    Device Name
    ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
    Manufacturer
    Date Cleared
    1997-08-05

    (336 days)

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

    TOPSLANE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ARTP (Anti-Tumor Radiation Treatment Planning System) is a radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic. ARTP is used to plan and simulate radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
    Device Description
    The TOPSLANE ATES is a Radiotherapy Treatment Planning System (RTPS) for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ATES is using modem photon beam convolution dose calculation algorithm and electron pencil beam dose calculation algorithm. The system software is designed to be convenient and low cost to the user.
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