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universal digital interface udi 1717
Meridian Medical Systems
Summary: The Universal Digital Interface UDI 1717 by Meridian Medical Systems is a Class 2 medical device used primarily in tumor ablation procedures. It is designed for use by oncologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K103599 ↗
Decision Date
April 27, 2011
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The Universal Digital Interface UDI 1717 was cleared through the FDA 510k pathway on April 27, 2011. 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 UDI 1717 is a digital interface device designed to integrate with various tumor ablation systems. It facilitates the precise control and monitoring of ablation procedures, ensuring accurate delivery of energy to target tissues. The device supports clinicians in achieving optimal therapeutic outcomes by providing real-time data and feedback during procedures.
Clinical Applications
This device is commonly used in interventional oncology settings for the treatment of tumors through ablation techniques. It is particularly useful in procedures involving the liver, lungs, kidneys, and other organs where precise ablation is critical. Oncologists and interventional radiologists utilize this device in both inpatient and outpatient settings to treat a variety of patient populations, including those with primary or metastatic tumors.
Indications for Use
The FDA-cleared indications for the Universal Digital Interface UDI 1717 involve its use in tumor ablation procedures. It is intended for patients requiring precise ablation of tumors, particularly in organs such as the liver and lungs, where accurate energy delivery is crucial.
Practical Considerations
The device is compatible with a range of ablation systems, making it versatile in various clinical settings. Clinicians should ensure proper calibration and integration with existing equipment for optimal performance. The interface is designed to be user-friendly, facilitating ease of use during complex procedures.
Frequently Asked Questions
What is the Universal Digital Interface UDI 1717 used for?
It is used for integrating and controlling tumor ablation systems, ensuring precise energy delivery during ablation procedures.
What specialties typically use this device?
Oncologists and interventional radiologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly in organs like the liver and lungs, requiring precise energy delivery.
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.