đź“‹ FDA Reference
Multimode Tm Interface Sys for Everest Jenning
Dufco Electronics
Summary: The Multimode TM Interface System for Everest Jenning, manufactured by Dufco Electronics, is an FDA-cleared device used primarily for tumor ablation. It is typically utilized by oncologists and interventional radiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K881464 ↗
Decision Date ?
July 18, 1988
Product Code ?
ITI
Device Class ?
Class 2
Evidence ?
0 studies
The Multimode TM Interface System for Everest Jenning was cleared through the FDA 510(k) pathway on July 18, 1988. Manufactured by Dufco Electronics, it is classified as a Class 2 device under product code ITI.
What It Is
The Multimode TM Interface System is a medical device designed for the ablation of tumors. It operates by delivering energy to targeted tissues, causing localized heating and destruction of tumor cells. This system is particularly useful in minimally invasive procedures, allowing for precise targeting and reduced recovery times.
FDA-Cleared Indications
- Ablation of tumors, according to the available device record.
Clinical Applications
- Use as part of a tumor-ablation procedure in a clinical setting.
- Use in image-guided minimally invasive treatment when the system is compatible with the imaging and ablation equipment specified in its labeling.
Practical Considerations
- The available record does not specify the system's energy source, applicator configuration, treatment sizes, or compatible accessories; clinicians should consult the original FDA-cleared labeling and manufacturer instructions.
- Tumor size, location, tissue characteristics, and proximity to critical structures affect whether ablation is appropriate and whether complete treatment is technically feasible.
- Confirm compatibility with the planned imaging system, generator, probes, cables, and other accessories before use.
- MRI safety and compatibility are not established by the information provided; do not use the system in or near an MRI environment unless the device labeling specifically permits it.
- Contraindications, anesthesia requirements, grounding or monitoring requirements, and handling instructions should be taken from the original instructions for use.
Frequently Asked Questions
What is the Multimode TM Interface System used for?
It is used for the ablation of tumors, particularly in minimally invasive oncology procedures.
What specialties typically use this device?
Oncologists and interventional radiologists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of tumors, specifically targeting cancerous tissues in patients with certain types of 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.