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focus rtp
Computerized Medical Systems
Summary: The focus rtp is a radiotherapy treatment planning system by Computerized Medical Systems, primarily used for dose distribution calculations in heterogeneous tissues. Key evidence highlights its implementation of convolution/superposition algorithms for accurate photon dose calculations.
FDA Clearance Information
Pathway
510K
Number
K915691 ↗
Decision Date
February 16, 1995
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The focus rtp was cleared by the FDA through the 510(k) pathway on February 16, 1995. It is manufactured by Computerized Medical Systems and is classified as a Class 2 device under product code MUJ.
What It Is
The focus rtp is a radiotherapy treatment planning system designed to calculate dose distributions in heterogeneous tissues. It utilizes advanced algorithms such as FFT convolution and multigrid superposition to enhance accuracy in photon dose calculations.
Clinical Applications
The focus rtp is commonly used in clinical scenarios requiring precise radiotherapy treatment planning, particularly in cases involving tissue inhomogeneities. It is integral in planning therapeutic treatments by evaluating dose distributions in target and surrounding normal structures.
Evidence Summary
The available literature includes 8 studies, primarily focusing on the implementation and accuracy of the focus rtp system's algorithms. These studies range from 2000 to 2002 and include various study types such as RCTs and retrospective analyses.
Reported Outcomes
Published studies report that the focus rtp system provides accurate dose distribution calculations in heterogeneous tissues. The implementation of FFT convolution and multigrid superposition models has been shown to improve the precision of photon dose calculations, enhancing treatment planning efficacy.
Safety Profile
Reported complications include potential inaccuracies in dose calculations due to tissue inhomogeneities. However, the studies reviewed did not provide detailed safety data or adverse event reports specific to the focus rtp system.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent research. Further studies are needed to evaluate long-term outcomes and safety in diverse clinical settings. Additionally, more comprehensive safety data would enhance understanding of potential complications.
Frequently Asked Questions
What are the clinical indications for focus rtp?
The focus rtp is indicated for use in radiotherapy treatment planning, particularly in cases requiring accurate dose distribution calculations in heterogeneous tissues.
What outcomes have been reported in clinical studies?
Studies have reported that the focus rtp system provides accurate and precise dose distribution calculations, improving treatment planning efficacy.
What complications have been reported?
Reported complications include potential inaccuracies in dose calculations due to tissue inhomogeneities, though detailed safety data is limited.
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.