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universal digital interface 2w udi 2w
Meridian Medical Systems
Summary: The Universal Digital Interface 2W by Meridian Medical Systems is a Class 2 medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists to enhance the precision of ablation therapies.
FDA Clearance Information
Pathway
510K
Number
K143232 ↗
Decision Date
January 30, 2015
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The Universal Digital Interface 2W was cleared through the FDA 510(k) pathway on January 30, 2015. Manufactured by Meridian Medical Systems, it is classified as a Class 2 device under product code MQB.
What It Is
The Universal Digital Interface 2W is a digital interface device designed to integrate with tumor ablation systems. It facilitates the precise delivery of energy to target tissues, enhancing the effectiveness of ablation procedures. The device works by providing a universal connection point for various ablation technologies, ensuring compatibility and improving procedural accuracy.
Clinical Applications
This device is commonly used in interventional oncology settings, particularly for procedures involving tumor ablation. It is suitable for use in hospitals and specialized cancer treatment centers. The device is often employed in treating patients with liver, lung, or kidney tumors, where precise ablation is critical for effective treatment outcomes.
Indications for Use
The FDA indications for the Universal Digital Interface 2W focus on its use in tumor ablation procedures. It is intended for patients requiring precise energy delivery to ablate cancerous tissues, particularly in organs like the liver and lungs.
Practical Considerations
The Universal Digital Interface 2W is designed to be compatible with a range of ablation systems, offering flexibility in clinical settings. Clinicians should ensure proper connection and calibration before use to optimize performance. The device's universal design supports various procedural techniques, enhancing its utility across different ablation technologies.
Frequently Asked Questions
What is Universal Digital Interface 2W used for?
The device is used to facilitate precise energy delivery in tumor ablation procedures, improving the accuracy and effectiveness of the treatment.
What specialties typically use this device?
Oncologists and interventional radiologists typically use this device in cancer treatment centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly for patients with tumors in organs such as the liver and lungs.
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.