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standard imaging e imrt calculator
Standard Imaging
Summary: The Standard Imaging e IMRT Calculator is a device used in radiation therapy planning, specifically for intensity modulated radiation therapy (IMRT). Key evidence highlights its role in transitioning treatment techniques and dosimetric advantages.
FDA Clearance Information
Pathway
510K
Number
K040688 ↗
Decision Date
May 11, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Standard Imaging e IMRT Calculator was cleared by the FDA through the 510(k) pathway on May 11, 2004. It is manufactured by Standard Imaging and is classified as a Class 2 device.
What It Is
The Standard Imaging e IMRT Calculator is a medical device designed to assist in the planning of intensity modulated radiation therapy (IMRT). It calculates the necessary parameters for precise radiation dose delivery, ensuring accurate treatment planning.
Clinical Applications
This device is commonly used in clinical scenarios involving complex radiation therapy planning, such as total body irradiation and treatment of head and neck cancers. It aids in optimizing dose distribution and minimizing exposure to surrounding healthy tissues.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as prospective and retrospective analyses, with publication years ranging from 2020 to 2024. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report that the Standard Imaging e IMRT Calculator facilitates accurate dose calculations and enhances treatment planning efficiency. It has been shown to support transitions from traditional techniques to advanced IMRT methods, offering dosimetric benefits in specific cancer treatments.
Safety Profile
Reported complications include minimal adverse events related to the device's use, with no significant safety concerns highlighted in the reviewed studies. The device is generally considered safe when used as intended in clinical settings.
Evidence Limitations
The evidence base is limited by the lack of large-scale randomized controlled trials specifically evaluating the device. Further research is needed to explore long-term outcomes and potential benefits in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Standard Imaging e IMRT Calculator?
The device is indicated for use in radiation therapy planning, particularly for intensity modulated radiation therapy (IMRT) in various cancer treatments.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in dose calculations and enhanced treatment planning efficiency, particularly in transitioning to advanced IMRT techniques.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with no significant complications associated with the device's use.
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.