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 for tumor ablation procedures. It is primarily utilized by interventional radiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
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.
FDA-Cleared Indications
- Use during tumor ablation procedures.
- Use to facilitate digital communication between ablation equipment and imaging systems when supported by the system labeling.
- Use in clinical settings according to the manufacturer’s compatibility and operating instructions.
Clinical Applications
- Digital integration of imaging information with tumor ablation equipment.
- Support for image-guided targeting during ablation procedures.
- Use in interventional radiology or oncology settings performing tumor ablation, when the connected equipment is compatible.
Practical Considerations
- The FDA record provided does not specify device dimensions, connector types, supported imaging modalities, or compatible ablation systems; users should verify compatibility before use.
- The record does not establish MRI safety. MRI use should not be assumed unless the device labeling identifies it as MR Safe or MR Conditional and specifies the conditions.
- The interface should be operated by trained clinical personnel according to the manufacturer’s instructions and the labeling for the connected imaging and ablation systems.
- The device is an interface component rather than a standalone tumor-treatment system; clinical results depend on the connected ablation equipment, imaging system, and treatment plan.
- Contraindications, cleaning requirements, maintenance, and service life should be taken from the current manufacturer’s labeling.
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.