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universal digital interface 2 udi 2
Meridian Medical Systems
Summary: The Universal Digital Interface 2 (UDI 2) by Meridian Medical Systems is a Class 2 medical device used primarily in tumor ablation procedures. It is designed for use by interventional radiologists and oncologists in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K140251 ↗
Decision Date
October 22, 2014
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The Universal Digital Interface 2 UDI 2 was cleared through the FDA 510(k) pathway on October 22, 2014. Manufactured by Meridian Medical Systems, it is classified as a Class 2 device under product code MQB.
What It Is
The Universal Digital Interface 2 UDI 2 is a digital interface device used in conjunction with ablation systems to treat tumors. It facilitates the precise delivery of energy to target tissues, enabling effective ablation. The device integrates with existing ablation equipment to enhance control and monitoring during procedures, ensuring accurate and safe treatment outcomes.
Clinical Applications
This device is commonly used in interventional radiology and oncology for the ablation of tumors in various organs, such as the liver, kidneys, and lungs. It is particularly useful in minimally invasive procedures where precise energy delivery is critical. The UDI 2 is suitable for use in both hospital and outpatient settings, catering to adult patients with solid tumors requiring ablation.
Indications for Use
The FDA-cleared indications for the UDI 2 involve its use in tumor ablation procedures. It is intended for patients with solid tumors that are accessible for minimally invasive treatment, providing an option for those who may not be candidates for surgical resection.
Practical Considerations
The Universal Digital Interface 2 is compatible with a range of ablation systems, offering flexibility in clinical practice. Clinicians should ensure proper integration with existing equipment and be familiar with the device's interface for optimal use. Training on the device's operation may be beneficial to maximize its capabilities.
Frequently Asked Questions
What is Universal Digital Interface 2 UDI 2 used for?
The UDI 2 is used for the ablation of tumors, facilitating precise energy delivery during minimally invasive procedures.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in the ablation of solid tumors, providing a treatment option for patients with accessible tumors.
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.