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intelliblate microwave ablation system console ib-con intelliblate microwave ablation system mobile cart ib-cart intelliblate ximitry probe assembly 13g x 15cm ib-xpa-1315 intelliblate ximitry probe assembly 13g x 20cm ib-xpa-1320 intelliblate ximitry probe assembly 13g x 27cm ib-xpa-1327
Varian Medical Systems
Summary: The Intelliblate Microwave Ablation System is a medical device used for the ablation of tumors. It is primarily used by interventional radiologists and oncologists to treat patients with certain types of tumors.
FDA Clearance Information
Pathway
510K
Number
K240480 ↗
Decision Date
July 19, 2024
Product Code
NEY
Device Class
Class 2
Evidence
0 studies
The Intelliblate Microwave Ablation System was cleared through the FDA 510(k) pathway on July 19, 2024. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code NEY.
What It Is
The Intelliblate Microwave Ablation System is a device designed for the thermal ablation of tumors using microwave energy. It includes a console, a mobile cart, and various probe assemblies that deliver microwave energy to targeted tissue. This system works by generating heat through microwave energy, which destroys tumor cells while sparing surrounding healthy tissue.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of liver, lung, kidney, and bone tumors. It is particularly useful in minimally invasive procedures where precise targeting of tumor tissue is required. The system is suitable for both inpatient and outpatient settings, providing flexibility in treatment planning for diverse patient populations.
Indications for Use
The FDA indications for this device include the ablation of soft tissue tumors. It is suitable for patients with tumors that are accessible via percutaneous or laparoscopic approaches, particularly when surgical resection is not feasible.
Practical Considerations
The Intelliblate system offers probes in various lengths (15cm, 20cm, and 27cm) to accommodate different tumor sizes and locations. Clinicians should consider the tumor's proximity to critical structures and the patient's overall health when planning treatment. Compatibility with imaging systems for real-time guidance is essential for optimal outcomes.
Frequently Asked Questions
What is the Intelliblate Microwave Ablation System used for?
It is used for the thermal ablation of tumors in various organs, including the liver, lung, kidney, and bone.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, particularly when surgical options are limited or not feasible.
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.