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510(k) Data Aggregation

    K Number
    K993766
    Device Name
    HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
    Manufacturer
    HELAX AB
    Date Cleared
    1999-12-08

    (30 days)

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

    HELAX AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or Brachytherapy treatment in the Oncology clinic. The system is designed to lead the user through a logical flow planning process. Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with: - linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 to 50MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus. - Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the Oncology clinic. Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.
    Device Description
    Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and Brachytherapy treatment in the oncology clinic. TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, and a Gaussian pencil beam model for electrons. A Brachytherapy module is integrated into TMS for treatment modeling of interstitial and intracavity Brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.
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    K Number
    K982857
    Device Name
    HELAX-IMCON, VERSION 1.0
    Manufacturer
    HELAX AB
    Date Cleared
    1998-11-04

    (83 days)

    Product Code
    KPQ
    Regulation Number
    892.5840
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELAX AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Patients planned for radiation treatment, either to verify a prescribed plan, or to help at the planning at the simulator.
    Device Description
    Helax-IMCON is an image workstation that replaces the fluoroscopic monitor at a radiotherapy simulator. It is connected to the video signal from the image intensifier of the simulator and the X-ray images are captured by a frame grabber and converted to digital images.
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    K Number
    K972617
    Device Name
    HELAX-VISIR
    Manufacturer
    HELAX AB
    Date Cleared
    1997-10-01

    (84 days)

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

    HELAX AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    radiation treatment Patients undergoing according to prescribed treatment plan.
    Device Description
    The Helax-VISIR system is a modern product for improved treatment management and quality assurance in Radiotherapy. The increasing complexity of treatment techniques and equipment requires a flexible and vendor-independent system for the booking, set-up, verification and documentation of the radiotherapy process.
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