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adac pinnacle3tm radiation therapy planning system
Adac Laboratories
Summary: The Adac Pinnacle3TM is a radiation therapy planning system used primarily for intensity modulated radiation therapy (IMRT). Key evidence highlights its application in CNS malignancies and cervical cancer, with studies exploring its efficacy and planning accuracy.
FDA Clearance Information
Pathway
510K
Number
K993923 ↗
Decision Date
April 7, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Adac Pinnacle3TM was cleared by the FDA via the 510(k) pathway on April 7, 2000. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code MUJ.
What It Is
The Adac Pinnacle3TM is a radiation therapy planning system designed to optimize treatment plans for patients undergoing radiation therapy. It is used to calculate and simulate radiation dose distributions, particularly for intensity modulated radiation therapy (IMRT).
Clinical Applications
The device is commonly used in planning radiation therapy for various cancers, including central nervous system malignancies and advanced cervical cancer. It aids clinicians in creating precise treatment plans to maximize tumor control while minimizing exposure to healthy tissues.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2006 to 2014, focusing on the efficacy and planning accuracy of the Pinnacle3TM system.
Reported Outcomes
Published studies report that the Adac Pinnacle3TM system effectively aids in the planning of radiation therapy, particularly for CNS malignancies and cervical cancer. It has been shown to improve dose conformity and reduce exposure to healthy tissues, enhancing treatment precision.
Safety Profile
Reported complications include potential inaccuracies in dose computation and variations in treatment planning across institutions. However, no specific adverse events directly attributable to the device were highlighted in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize planning protocols and assess long-term outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Adac Pinnacle3TM?
The Adac Pinnacle3TM is indicated for use in planning radiation therapy, particularly intensity modulated radiation therapy (IMRT) for cancers such as CNS malignancies and advanced cervical cancer.
What outcomes have been reported in clinical studies?
Studies have reported improved dose conformity and reduced exposure to healthy tissues, enhancing treatment precision in CNS malignancies and cervical cancer.
What complications have been reported?
Safety data indicate potential inaccuracies in dose computation and interinstitutional planning variations, but no specific adverse events directly linked to the device were noted.
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.