📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies Radiance with dialysis vascular access under product code MUJ.
- The available FDA summary does not specify the exact access configuration, anatomy, patient population, or procedural steps.
Clinical Applications
- Use in clinical settings where vascular access is required for dialysis treatment.
- Use during dialysis care when reliable access to the vascular system is needed.
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.
Practical Considerations
- The available record does not state the device type, dimensions, lumen configuration, compatible accessories, or recommended handling technique.
- Confirm the current manufacturer instructions for use before use, including access-site requirements, contraindications, and storage conditions.
- MRI safety and conditional labeling are not established in the information provided; verify the device-specific MRI labeling before scanning.
- Device selection should account for the patient's vascular anatomy, dialysis prescription, access history, infection risk, and the requirements of the planned procedure.
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.