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universal digital interface wireless - udi 1417w
Meridian Medical Systems
Summary: The Universal Digital Interface Wireless by Meridian Medical Systems is a Class 2 medical device cleared by the FDA for use in tumor ablation. Key evidence includes studies on wireless communication and sensor systems.
FDA Clearance Information
Pathway
510K
Number
K111305 ↗
Decision Date
January 31, 2012
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 31, 2012. It is manufactured by Meridian Medical Systems and classified as a Class 2 device under product code MQB.
What It Is
The Universal Digital Interface Wireless is a device designed to facilitate wireless communication in clinical settings, particularly for tumor ablation procedures. It integrates digital interfaces to support various medical applications.
Clinical Applications
Commonly used in tumor ablation procedures, this device provides a wireless interface for clinicians to monitor and control ablation processes. It is particularly useful in settings requiring minimal physical connectivity.
Evidence Summary
The available literature includes 7 studies, with publication dates ranging from 2014 to 2024. These studies encompass various types, including RCTs and case series, focusing on wireless communication and sensor technologies.
Reported Outcomes
Published studies report advancements in wireless communication technologies and their applications in medical devices. However, specific efficacy outcomes related to tumor ablation are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues with wireless signal interference and device integration in clinical environments. Specific adverse events related to tumor ablation are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on clinical outcomes related to tumor ablation. Further research is needed to evaluate the device's efficacy and safety in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for universal digital interface wireless?
The device is indicated for use in tumor ablation procedures, providing a wireless interface for clinical applications.
What outcomes have been reported in clinical studies?
Studies focus on the integration of wireless communication technologies, but specific clinical outcomes for tumor ablation are not detailed.
What complications have been reported?
Safety data indicate potential wireless signal interference and integration challenges, but specific complications in tumor ablation are not reported.
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.