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acumen insight endocardial visualization system
Acumen Medical
Summary: The Acumen Insight Endocardial Visualization System is a medical device used for visualizing the interior of the heart. It is primarily used by cardiologists in procedures involving venous stents.
FDA Clearance Information
Pathway 510K
Number K070051 ↗
Decision Date April 6, 2007
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Acumen Insight Endocardial Visualization System was cleared through the FDA 510(k) pathway on April 6, 2007. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DQY.
What It Is
The Acumen Insight Endocardial Visualization System is designed to provide real-time imaging of the heart's interior structures. It utilizes advanced imaging technology to assist clinicians in visualizing the endocardial surface, which is crucial during procedures involving the placement of venous stents. This system enhances the accuracy and safety of such interventions by offering detailed visualization.
Clinical Applications
This device is commonly used in cardiology, particularly in interventional cardiology procedures. It is employed in settings such as cardiac catheterization labs, where precise visualization of the heart's interior is necessary. The system is beneficial for patients undergoing procedures that involve the placement or adjustment of venous stents, aiding in the accurate deployment and assessment of stent positioning.
Indications for Use
The FDA-cleared indications for this device involve its use in visualizing the endocardial surface during procedures that require detailed imaging of the heart's interior. It is particularly useful for patients who need venous stents, ensuring proper placement and function.
Practical Considerations
Clinicians should consider the compatibility of the Acumen Insight System with existing catheterization lab equipment. The device typically comes in various sizes to accommodate different patient anatomies, and proper training is essential to maximize its imaging capabilities during procedures.
Frequently Asked Questions
What is the Acumen Insight Endocardial Visualization System used for?
It is used for visualizing the interior of the heart, particularly during procedures involving venous stents.
What specialties typically use this device?
This device is primarily used by interventional cardiologists in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for visualizing the endocardial surface during procedures that require detailed imaging of the heart, especially for venous stent placement.
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.