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core fm system patient interface module opim hemodynamic converter box
Volcano
Summary: The Core FM System Patient Interface Module by Volcano is a hemodynamic converter box used in tumor ablation procedures. It's typically used by interventional radiologists and oncologists to monitor and manage hemodynamic parameters during ablation.
FDA Clearance Information
Pathway
510K
Number
K152582 ↗
Decision Date
December 3, 2015
Product Code
DSK
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 3, 2015, by Volcano. It is classified as a Class 2 device under product code DSK.
What It Is
The Core FM System Patient Interface Module is a medical device designed to convert and monitor hemodynamic signals during tumor ablation procedures. It integrates with other ablation systems to provide real-time data on blood flow and pressure, aiding clinicians in making informed decisions during treatment. This device is particularly useful in ensuring precise ablation and minimizing damage to surrounding tissues.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings, particularly during procedures involving tumor ablation. It is suitable for use in hospitals and specialized cancer treatment centers. The device is used for patients undergoing treatment for various types of tumors, including renal cell carcinoma, where precise monitoring of hemodynamic parameters is crucial.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving tumor ablation, where monitoring of hemodynamic parameters is necessary. It is particularly relevant for patients with tumors requiring precise ablation techniques.
Practical Considerations
The Core FM System Patient Interface Module is compatible with a range of ablation devices. Clinicians should ensure proper integration with existing systems and verify compatibility with the specific ablation equipment in use. Proper training in the use of hemodynamic monitoring is recommended for optimal results.
Related Literature
The linked study investigated the tumor immune microenvironment in metastatic renal cell carcinoma and its correlation with immunotherapy response. Using quantitative multiplexed immunofluorescence, the study analyzed immune cell densities in different tumor regions. Significant associations were found between immune cell distribution patterns and survival outcomes. However, the study was limited by its small sample size of 39 patients.
Frequently Asked Questions
What is the Core FM System Patient Interface Module used for?
It is used for monitoring and converting hemodynamic signals during tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving tumor ablation where hemodynamic monitoring is necessary.
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.