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volcano preview forward-looking ivus system
Volcano
Summary: The Volcano Preview Forward-Looking IVUS System is an intravascular ultrasound device used for imaging within blood vessels, primarily by cardiologists and interventional radiologists. It aids in the assessment and treatment of vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K132659 ↗
Decision Date
September 27, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Volcano Preview Forward-Looking IVUS System was cleared via the FDA 510(k) pathway on September 27, 2013, by Volcano. It is classified as a Class 2 device under product code DQY.
What It Is
The Volcano Preview Forward-Looking IVUS System is an advanced intravascular ultrasound device designed to provide real-time imaging from within blood vessels. It utilizes ultrasound technology to create detailed images of the vessel walls and lumen, aiding in the diagnosis and management of vascular diseases. This forward-looking capability allows for enhanced visualization ahead of the catheter tip, which is particularly useful in navigating complex vascular anatomy.
Clinical Applications
This device is commonly used in interventional cardiology and radiology, particularly during procedures involving venous stents. It helps clinicians assess the condition of blood vessels, plan interventions, and evaluate the placement and effectiveness of stents. The system is especially beneficial in patients with complex vascular conditions, providing detailed images that guide therapeutic decisions.
Indications for Use
The FDA indications for this device include its use in imaging within blood vessels to assist in the placement and assessment of venous stents. It is intended for patients requiring detailed vascular imaging to guide treatment decisions.
Practical Considerations
Clinicians should be aware of the device's compatibility with existing catheter systems and its ability to provide forward-looking imaging, which can be crucial in complex cases. Proper training in the use of IVUS technology is recommended to maximize the device's diagnostic and therapeutic benefits.
Frequently Asked Questions
What is the Volcano Preview Forward-Looking IVUS System used for?
It is used for intravascular imaging to assess and guide the treatment of vascular conditions, particularly in the placement and evaluation of venous stents.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for imaging within blood vessels to assist in the placement and assessment of venous stents.
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.