Search Results
Found 3 results
510(k) Data Aggregation
K Number
K993766Device 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
892.5050Why 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.
Ask a Question
K Number
K982857Device Name
HELAX-IMCON, VERSION 1.0
Manufacturer
HELAX AB
Date Cleared
1998-11-04
(83 days)
Product Code
KPQ
Regulation Number
892.5840Why 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.
Ask a Question
K Number
K972617Device Name
HELAX-VISIR
Manufacturer
HELAX AB
Date Cleared
1997-10-01
(84 days)
Product Code
IYE
Regulation Number
892.5050Why 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.
Ask a Question
Page 1 of 1