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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 for tumor ablation procedures. It is primarily utilized by interventional radiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K112527 ↗
Decision Date
May 22, 2012
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The Universal Digital Interface UDI 1717 was cleared through the FDA 510(k) pathway on May 22, 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 UDI 1717 is a medical device designed to facilitate digital communication between ablation equipment and imaging systems. It enhances the precision of tumor ablation procedures by integrating real-time imaging data, allowing clinicians to target tumors more accurately. This device is particularly valuable in minimally invasive procedures where precise localization of the ablation site is critical.
Clinical Applications
This device is commonly used in interventional radiology and oncology for tumor ablation procedures. It is particularly useful in hospitals and specialized cancer treatment centers where precise imaging and ablation are required. The UDI 1717 is suitable for treating patients with solid tumors, providing a digital interface that enhances the accuracy of ablation treatments.
Indications for Use
The FDA indications for the UDI 1717 involve its use in tumor ablation procedures. It is intended for patients with solid tumors that require precise ablation, helping clinicians to effectively target and treat these tumors.
Practical Considerations
The Universal Digital Interface UDI 1717 is compatible with various imaging systems, making it versatile in different clinical settings. Clinicians should ensure compatibility with existing equipment and be trained in its use to maximize the benefits of enhanced imaging integration during ablation procedures.
Frequently Asked Questions
What is the Universal Digital Interface UDI 1717 used for?
It is used to facilitate digital communication between ablation equipment and imaging systems, enhancing precision in tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in settings that require precise tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly for patients with solid tumors requiring precise treatment.
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.