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the mirage system biofeedback interface
Intercare Diagnostics
Summary: The Mirage System Biofeedback Interface by Intercare Diagnostics is a Class 2 medical device used in tumor ablation procedures. It is primarily utilized by oncologists and radiologists to enhance precision during treatment.
FDA Clearance Information
Pathway
510K
Number
K941938 ↗
Decision Date
August 5, 1994
Product Code
HCC
Device Class
Class 2
Evidence
0 studies
The Mirage System Biofeedback Interface was cleared via the FDA 510(k) pathway on August 5, 1994. Manufactured by Intercare Diagnostics, it is classified as a Class 2 device under product code HCC.
What It Is
The Mirage System Biofeedback Interface is a medical device designed to provide real-time feedback during tumor ablation procedures. It integrates biofeedback technology to enhance the precision and effectiveness of ablation by allowing clinicians to monitor physiological responses. This system is particularly useful in ensuring accurate targeting and minimizing damage to surrounding healthy tissues.
Clinical Applications
Commonly used in oncology and radiology settings, the Mirage System Biofeedback Interface assists in procedures such as radiofrequency ablation or microwave ablation of tumors. It is particularly beneficial in treating patients with liver, lung, or kidney tumors, where precision is crucial. The device is typically employed in hospital settings or specialized cancer treatment centers.
Indications for Use
The FDA-cleared indications for the Mirage System Biofeedback Interface involve its use in tumor ablation procedures. It is intended for patients requiring precise ablation of tumors, helping clinicians to achieve better outcomes by providing real-time feedback during the procedure.
Practical Considerations
The Mirage System Biofeedback Interface is compatible with standard ablation equipment and is typically available in sizes suitable for various tumor locations. Clinicians should be trained in biofeedback techniques to maximize the device's potential. It is important to ensure compatibility with existing imaging and ablation systems.
Frequently Asked Questions
What is the Mirage System Biofeedback Interface used for?
It is used to provide real-time feedback during tumor ablation procedures, enhancing precision and effectiveness.
What specialties typically use this device?
Oncologists and radiologists typically use this device, especially in settings focused on tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, providing real-time feedback to improve precision.
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.