đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Image guidance for endovascular procedures requiring visualization of the aorta and vascular anatomy.
- Support for the positioning and deployment of aortic stent-grafts during endovascular aortic repair.
Clinical Applications
- Image-guided endovascular repair of abdominal aortic aneurysms.
- Image-guided endovascular repair of thoracic aortic aneurysms.
- Fluoroscopic visualization during aortic stent-graft positioning and deployment.
- Intraoperative imaging in hospital-based interventional radiology and vascular surgery procedures.
Practical Considerations
- This is an imaging system rather than an implantable device; it does not remain in the patient after the procedure.
- Compatibility with the facility's imaging suite, vascular imaging software, displays, tables and other accessories should be confirmed before use.
- Users should complete system-specific training and perform required setup, calibration and quality-control checks.
- The system uses ionizing radiation, so radiation-protection practices and dose monitoring are required for patients and staff.
- MRI compatibility depends on the specific system components and room configuration; the device should not be brought into an MRI environment unless the manufacturer has documented that configuration as MR safe or MR conditional.
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.