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pmt truscan surface electrode
Pmt
Summary: The PMT TruScan Surface Electrode is a medical device used for tumor ablation. It is primarily utilized by oncologists and surgeons in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K122376 ↗
Decision Date
December 19, 2012
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The PMT TruScan Surface Electrode was cleared through the FDA 510(k) pathway on December 19, 2012. It is manufactured by PMT and classified as a Class 2 medical device.
What It Is
The PMT TruScan Surface Electrode is a device designed for the ablation of tumors. It works by delivering electrical energy to target tissue, causing thermal destruction of tumor cells. This device is particularly useful in minimally invasive procedures where precision and control are paramount.
Clinical Applications
Clinically, the PMT TruScan Surface Electrode is used in procedures such as radiofrequency ablation for tumor treatment. It is commonly employed in oncology and surgical departments, especially in hospitals and specialized cancer treatment centers. The device is suitable for adult patients with tumors that are accessible for surface electrode application.
Indications for Use
The FDA-cleared indications suggest this device is intended for patients requiring tumor ablation. It is applicable for conditions where tumor reduction or removal is necessary, particularly in cases where other surgical options may not be feasible.
Practical Considerations
The PMT TruScan Surface Electrode comes in various sizes to accommodate different tumor sizes and locations. It is compatible with standard ablation generators. Clinicians should be trained in the specific technique for optimal results and to minimize complications.
Frequently Asked Questions
What is the PMT TruScan Surface Electrode used for?
It is used for the ablation of tumors, delivering electrical energy to destroy tumor cells.
What specialties typically use this device?
Oncology and surgical specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for tumor ablation in patients where tumor reduction or removal is needed.
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.