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radiance
Gmv Aerospace And Defence
Summary: Radiance is a dialysis-access device manufactured by Gmv Aerospace And Defence, cleared by the FDA via the 510k pathway. Key evidence includes 15 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K112060 ↗
Decision Date
January 6, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Radiance was cleared by the FDA through the 510k pathway on January 6, 2012. It is manufactured by Gmv Aerospace And Defence and classified as a Class 2 device under product code MUJ.
What It Is
Radiance is a medical device designed for dialysis access, facilitating efficient and safe vascular access for dialysis treatments. It is intended for use in clinical settings to support patients requiring dialysis.
Clinical Applications
Radiance is commonly used in scenarios requiring reliable vascular access for dialysis patients. It is particularly useful in hospital and outpatient settings where dialysis is routinely performed.
Evidence Summary
The available literature includes 15 studies, with various study types such as RCTs and case series, conducted between 2024 and 2025. These studies explore different aspects of the device's performance and safety.
Reported Outcomes
Published studies report that Radiance effectively supports dialysis access with a focus on maintaining vascular integrity. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues with vascular access integrity, although specific adverse events are not detailed in the provided evidence. Further research is needed to fully understand the safety profile.
Evidence Limitations
The evidence provided lacks detailed outcomes and safety data, indicating a need for more comprehensive studies. Future research should focus on long-term efficacy and safety outcomes to better inform clinical use.
Frequently Asked Questions
What are the clinical indications for Radiance?
Radiance is indicated for use in dialysis access, providing reliable vascular access for patients undergoing dialysis treatments.
What outcomes have been reported in clinical studies?
Specific efficacy outcomes are not detailed in the provided evidence, but Radiance is reported to support dialysis access effectively.
What complications have been reported?
Reported complications include potential issues with vascular access integrity, though specific adverse events are not detailed in the evidence.
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.