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micro thermx microwave ablation system and accessories
Bsd Medical
Summary: The MicroThermX Microwave Ablation System is a medical device used for the ablation of soft tissue tumors. It is primarily utilized by interventional radiologists and oncologists in a clinical setting.
FDA Clearance Information
Pathway 510K
Number K141785 ↗
Decision Date March 31, 2015
Product Code NEY
Device Class Class 2
Evidence 0 studies
The MicroThermX Microwave Ablation System, manufactured by BSD Medical, received FDA clearance through the 510k pathway on March 31, 2015. It is classified as a Class 2 device under product code NEY.
What It Is
The MicroThermX Microwave Ablation System is a medical device designed to deliver microwave energy to ablate, or destroy, soft tissue tumors. It operates by emitting microwave radiation, which generates heat and causes coagulative necrosis in the targeted tissue. This minimally invasive technique is often preferred for its precision and reduced recovery time compared to traditional surgical methods.
Clinical Applications
This device is commonly used in the treatment of liver, lung, kidney, and bone tumors. Interventional radiologists and oncologists frequently employ it in hospital settings, particularly in oncology departments. It is suitable for patients who are not candidates for surgery or those seeking a less invasive treatment option.
Indications for Use
The FDA-cleared indications for the MicroThermX Microwave Ablation System include the ablation of soft tissue tumors. This means it is intended for patients with tumors that can be targeted and treated with microwave energy, offering a non-surgical option for tumor management.
Practical Considerations
When using the MicroThermX system, clinicians should consider the size and location of the tumor to determine the appropriate probe and energy settings. It is compatible with various imaging modalities to guide placement and monitor treatment. Proper training in microwave ablation techniques is essential for optimal outcomes.
Frequently Asked Questions
What is the MicroThermX Microwave Ablation System used for?
It is used for the ablation of soft tissue tumors, providing a minimally invasive treatment option for patients with certain types of tumors.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital and clinical settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, offering a non-surgical option for managing tumors in various organs.
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.