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radiance v4
Gmv Soluciones Globales Internet S.A.U.
Summary: Radiance v4 is a dialysis-access device by Gmv Soluciones Globales Internet S.A.U., cleared by the FDA via 510k pathway. Limited evidence available with no specific outcomes or safety data reported.
FDA Clearance Information
Pathway
510K
Number
K171885 ↗
Decision Date
July 25, 2017
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Radiance v4 was cleared by the FDA through the 510k pathway on July 25, 2017. It is manufactured by Gmv Soluciones Globales Internet S.A.U. and classified as a Class 2 device under product code MUJ.
What It Is
Radiance v4 is a medical device designed for use in dialysis access procedures. It is intended to assist in the management of dialysis access, providing clinicians with a tool to facilitate patient care in this context.
Clinical Applications
The device is commonly used in scenarios requiring dialysis access, such as in patients undergoing renal dialysis. It aids in ensuring effective and efficient access to the vascular system for dialysis treatment.
Evidence Summary
The available literature includes two studies, though neither provides specific data on outcomes or safety related to the Radiance v4. The studies are from diverse fields and do not directly pertain to the device's clinical application.
Reported Outcomes
Published studies report no specific efficacy findings related to the Radiance v4. The linked studies do not provide relevant data on the device's performance in clinical settings.
Safety Profile
Reported complications include no specific adverse events or complications related to the Radiance v4, as the linked studies do not provide relevant safety data.
Evidence Limitations
The evidence base for the Radiance v4 is limited, with no direct studies on its clinical efficacy or safety. Further research is needed to establish comprehensive outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Radiance v4?
The device is indicated for use in dialysis access procedures, aiding in vascular access for dialysis treatment.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the available studies related to the Radiance v4.
What complications have been reported?
No specific complications have been reported in the available evidence for the Radiance v4.
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.