đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in tumor-ablation procedures as described in the FDA-cleared labeling.
- Integration with compatible tumor-ablation systems for procedure control or monitoring.
Clinical Applications
- Supporting image-guided ablation of tumors when used with compatible ablation equipment.
- Providing an interface for control or monitoring during tumor-ablation procedures.
- Use in interventional oncology procedures involving tumors when the complete system is used according to its labeling.
Practical Considerations
- Compatibility depends on the specific tumor-ablation system, software, connectors, and accessories; verify the equipment combination before use.
- The device should be installed, configured, and tested according to the manufacturer’s instructions by trained personnel.
- The available FDA record does not establish that the interface itself is MRI safe or MR conditional. Confirm the labeling for the complete system before use in or near an MRI environment.
- The FDA record provided does not specify device dimensions, patient-contacting components, or a replacement interval.
- Use should follow the labeling for the connected ablation system, including its contraindications, calibration requirements, and electrical-safety precautions.
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.