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physio-dyne easi easy analog sampling interface
Physio-Dyne Instrument
Summary: The Physio-Dyne EASI Easy Analog Sampling Interface is a medical device used for tumor ablation procedures. It is primarily utilized by oncologists and interventional radiologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K892670 ↗
Decision Date
September 22, 1989
Product Code
BZC
Device Class
Class 2
Evidence
0 studies
The Physio-Dyne EASI Easy Analog Sampling Interface was cleared through the FDA 510k pathway on September 22, 1989. It is manufactured by Physio-Dyne Instrument and classified as a Class 2 device.
What It Is
The Physio-Dyne EASI Easy Analog Sampling Interface is a device designed to facilitate the sampling of analog signals during medical procedures. It is particularly useful in tumor ablation, where precise monitoring and control of the procedure are crucial. The device interfaces with other equipment to ensure accurate data collection and analysis, aiding clinicians in achieving optimal outcomes.
Clinical Applications
This device is commonly used in tumor ablation procedures, which are performed to destroy cancerous tissues. It is utilized in oncology and interventional radiology settings, where precise monitoring of the ablation process is necessary. The device is suitable for use in hospitals and specialized cancer treatment centers, catering to adult and pediatric patients requiring tumor ablation.
Indications for Use
The FDA-cleared indications for this device include its use in procedures aimed at ablating tumors. It is intended for patients who require precise monitoring during such procedures, ensuring effective treatment of cancerous tissues.
Practical Considerations
The device is typically compatible with a range of ablation equipment, allowing for seamless integration into existing clinical workflows. Clinicians should ensure proper calibration and setup to maximize the accuracy of data collection. Familiarity with the device's interface and compatibility with other systems is essential for optimal use.
Frequently Asked Questions
What is the Physio-Dyne EASI Easy Analog Sampling Interface used for?
It is used for monitoring and sampling analog signals during tumor ablation procedures.
What specialties typically use this device?
Oncology and interventional radiology specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, providing precise monitoring and control during treatment.
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.