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vision 2 evarvision trackvision 2 heartvision 2
Ge Medical Systems Scs
Summary: The Vision 2 Evarvision Trackvision 2 Heartvision 2 is a medical imaging device used in endovascular procedures, particularly for aortic stent-grafts. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K223152 ↗
Decision Date
November 22, 2022
Product Code
LLZ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 22, 2022. Manufactured by Ge Medical Systems Scs, it is classified as a Class 2 device under product code LLZ.
What It Is
The Vision 2 Evarvision Trackvision 2 Heartvision 2 is an advanced imaging system designed to assist in the precise placement of aortic stent-grafts. It integrates real-time imaging with navigation capabilities, enhancing the accuracy and safety of endovascular procedures. This device is particularly valuable in complex vascular interventions where visualization is critical.
Clinical Applications
This device is commonly used in procedures involving the repair of abdominal and thoracic aortic aneurysms. It is typically employed in hospital settings, particularly in interventional radiology and vascular surgery departments. The primary patient population includes adults with aortic aneurysms requiring endovascular repair.
Indications for Use
The FDA indications suggest that this device is intended for use in patients undergoing endovascular aortic repair, specifically those requiring precise stent-graft placement. It is suitable for conditions such as abdominal aortic aneurysms and thoracic aortic aneurysms.
Practical Considerations
Clinicians should consider the compatibility of the device with existing imaging systems and ensure proper training in its use. The device's navigation features may require specific setup and calibration to optimize performance during procedures.
Frequently Asked Questions
What is Vision 2 Evarvision Trackvision 2 Heartvision 2 used for?
It is used for imaging and navigation during endovascular aortic repair procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in endovascular aortic repair, particularly for precise stent-graft placement in aortic aneurysms.
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.