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flexiplan 3d and 3d
Isodose Control
Summary: The flexiplan 3d and 3d by Isodose Control is a dialysis-access device cleared by the FDA. It is primarily used in treatment planning for radiation therapy. Key evidence includes studies on dose verification and dosimetric comparisons.
FDA Clearance Information
Pathway
510K
Number
K091145 ↗
Decision Date
May 27, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The flexiplan 3d and 3d was cleared by the FDA via the 510(k) pathway on May 27, 2009. It is manufactured by Isodose Control and classified as a Class 2 device.
What It Is
The flexiplan 3d and 3d is a medical device used in radiation therapy planning. It assists in creating precise treatment plans by accounting for anatomical variations and ensuring accurate dose delivery.
Clinical Applications
Commonly used in radiation therapy for conditions such as nasopharyngeal carcinoma, the device aids in planning and verifying treatment doses. It is particularly useful in scenarios requiring precise dose calculations and adjustments.
Evidence Summary
The available literature includes two studies published between 2014 and 2017. These studies involve dosimetric comparisons and treatment verification using advanced imaging and simulation techniques.
Reported Outcomes
Published studies report that the flexiplan 3d and 3d is effective in enhancing the accuracy of dose delivery in radiation therapy. The device facilitates precise treatment planning, which is crucial for effective cancer treatment.
Safety Profile
Reported complications include potential inaccuracies in dose calculations if not properly calibrated. However, the studies reviewed did not report significant adverse events directly attributed to the device.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to validate the device's efficacy across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for flexiplan 3d and 3d?
The device is indicated for use in radiation therapy planning, particularly in cases requiring precise dose calculations such as nasopharyngeal carcinoma.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in dose delivery and treatment planning, enhancing the effectiveness of radiation therapy.
What complications have been reported?
Safety data indicate potential inaccuracies in dose calculations if the device is not properly calibrated, but no significant adverse events have been directly linked to the device.
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.