đź“Š Evidence-Based Reference
pinnacle radiation therapy planning system
Philips Medical Systems (Cleveland)
Summary: The Pinnacle Radiation Therapy Planning System, manufactured by Philips Medical Systems, is used for planning radiation therapy treatments. Key evidence highlights its application in intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT).
FDA Clearance Information
Pathway
510K
Number
K170086 ↗
Decision Date
February 9, 2017
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Pinnacle Radiation Therapy Planning System was cleared by the FDA via the 510(k) pathway on February 9, 2017. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
The Pinnacle Radiation Therapy Planning System is a software tool designed to assist clinicians in planning radiation therapy treatments. It is used to optimize the delivery of radiation doses to target tissues while minimizing exposure to surrounding healthy tissues.
Clinical Applications
Common clinical scenarios for the Pinnacle system include planning treatments for various cancers using techniques such as IMRT and VMAT. It is particularly used in cases requiring precise dose distribution, such as prostate and nasopharyngeal carcinomas.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, retrospective analyses, and feasibility studies, published between 2018 and 2024. These studies explore the system's application in different cancer treatment scenarios.
Reported Outcomes
Published studies report that the Pinnacle system effectively aids in achieving optimal dose distribution in radiation therapy, particularly in IMRT and VMAT. It has been shown to improve organ-at-risk sparing and treatment planning efficiency in various cancer types.
Safety Profile
Reported complications include challenges in achieving optimal dose distribution in complex cases, which may lead to suboptimal treatment outcomes. However, no specific adverse events directly related to the device have been highlighted in the studies.
Evidence Limitations
Evidence gaps include a lack of large-scale randomized controlled trials directly comparing the Pinnacle system with other planning systems. Further research is needed to explore its long-term clinical outcomes and cost-effectiveness.
Frequently Asked Questions
What are the clinical indications for Pinnacle Radiation Therapy Planning System?
The system is indicated for planning radiation therapy treatments, particularly using IMRT and VMAT techniques, in various cancer types.
What outcomes have been reported in clinical studies?
Studies have reported effective dose distribution and improved organ-at-risk sparing in radiation therapy planning.
What complications have been reported?
Challenges in achieving optimal dose distribution in complex cases have been reported, but no specific adverse events related to the device itself.
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.