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raydose
Raysearch Laboratories Ab
Summary: Raydose is a dialysis-access device used for precise dosimetry in radiation therapy. Key evidence includes studies on dosimetry characteristics and dose verification.
FDA Clearance Information
Pathway
510K
Number
K082221 ↗
Decision Date
October 22, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Raydose was cleared through the FDA 510(k) pathway on October 22, 2008. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device.
What It Is
Raydose is a medical device designed for dosimetry in radiation therapy, particularly in dialysis-access scenarios. It is intended to provide accurate dose measurements to enhance treatment precision.
Clinical Applications
Raydose is commonly used in clinical settings requiring precise radiation dose calculations, such as in intensity-modulated radiation therapy (IMRT) and peptide receptor radionuclide therapy (PRRT).
Evidence Summary
The available literature includes six studies, with a mix of study types such as RCTs and retrospective analyses, conducted between 2018 and 2024.
Reported Outcomes
Published studies report that Raydose provides accurate dosimetry measurements, which are critical for effective radiation therapy planning. The device has been validated in various dosimetry systems and imaging modalities, demonstrating its utility in clinical practice.
Safety Profile
Reported complications include potential inaccuracies in dose calculations if image registration is not properly performed. No direct adverse events related to the device itself were noted in the studies.
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 explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for raydose?
Raydose is indicated for use in radiation therapy dosimetry, particularly in scenarios requiring precise dose calculations such as IMRT and PRRT.
What outcomes have been reported in clinical studies?
Studies have reported accurate dosimetry measurements and effective dose verification, enhancing the precision of radiation therapy.
What complications have been reported?
Reported complications include potential inaccuracies in dose calculations due to improper image registration, though no direct adverse events 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.