📊 Evidence-Based Reference
Tigrt Tps
Linatech
Summary: The TiGRT TPS by Linatech is a treatment planning system used primarily in radiation therapy. Key evidence highlights its accuracy in dose calculations for various clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090893 ↗
Decision Date ?
July 15, 2009
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The TiGRT TPS was cleared by the FDA via the 510(k) pathway on July 15, 2009. It is manufactured by Linatech and classified as a Class 2 device.
What It Is
The TiGRT TPS is a treatment planning system designed for use in radiation therapy. It assists clinicians in planning and verifying radiation doses to ensure accurate treatment delivery.
FDA-Cleared Indications
- Treatment planning for external-beam radiation therapy.
- Calculation and verification of radiation dose distributions for radiation treatment plans.
- Planning of complex radiation therapy treatments, including intensity-modulated treatment techniques, when supported by the cleared system configuration.
Clinical Applications
- Creating treatment plans for external-beam radiation therapy.
- Calculating radiation dose distributions for planned treatments.
- Reviewing and verifying radiation therapy plans before treatment delivery.
- Supporting computer-based planning for complex radiotherapy cases.
Evidence Summary
The available literature includes 8 studies, ranging from randomized controlled trials to retrospective analyses, published between 2018 and 2024. These studies focus on the accuracy and verification of dose calculations.
Reported Outcomes
Published studies report that the TiGRT TPS demonstrates high accuracy in dose calculations for small photon beams and complex treatment areas, such as the head and neck and breast regions. It is effective in ensuring precise treatment delivery in radiation therapy.
Safety Profile
Reported complications include potential inaccuracies in dose delivery if not properly calibrated, particularly in small field sizes. However, no significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Practical Considerations
- TiGRT TPS is software rather than an implanted or catheter-based device; it does not have a physical patient size or vessel diameter.
- Use depends on compatibility with the radiation therapy equipment, imaging data, treatment-delivery system, and clinical workflow available at the treatment center.
- Radiation dose calculations and plan quality require review and approval by qualified radiation oncology professionals.
- The system is not an MRI device and should not be considered MRI-safe or MRI-conditional without specific manufacturer labeling for the installed configuration.
- The FDA record identifies a Class II 510(k)-cleared device; the clearance does not replace institution-specific commissioning, quality assurance, or clinical protocols.
Frequently Asked Questions
What are the clinical indications for TiGRT TPS?
TiGRT TPS is indicated for use in radiation therapy planning, particularly in IMRT and IGRT for cancers such as head and neck and breast.
What outcomes have been reported in clinical studies?
Studies report high accuracy in dose calculations, particularly for small photon beams and complex treatment areas.
What complications have been reported?
Safety data indicate potential inaccuracies in dose delivery if not properly calibrated, especially in small field sizes.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.