Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP
by GE Medical Systems SCS 510(k)
Active
510(k) K092639
Overview
The Innova Vision (Models S18751VN, S18751VT, S18751EP) is a Class II X-ray imaging system designed for fluoroscopic and radiographic procedures. These models integrate advanced imaging capabilities, including segmented DICOM 3D datasets and live fluoroscopy, to support diagnostic and interventional radiology workflows. The system is configured for use in vascular, orthopedic, and electrophysiology procedures, providing real-time visualization and tracking functionalities. Each model variant is tailored for specific procedural needs, such as vascular navigation (TrackVision) or electrophysiology (EPVision).
The device is supplied as a standalone X-ray system with integrated software applications running on the Advantage Workstation platform. It is intended for single-use or reusable components as specified by the manufacturer, with imaging components requiring appropriate sterilization protocols. The system is MRI-unsafe and must be used in environments compliant with radiation safety standards. Models are available in distinct configurations (S18751VN, S18751VT, S18751EP) to accommodate different clinical specialties, and storage requirements align with standard X-ray imaging equipment. FDA clearance under 510(k) (K092639) was granted in 2009 for use in radiology procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092639 | Date2 Dec 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from GE Medical Systems SCS
Questions
What clinical procedures is the Innova Vision system designed for?
The Innova Vision system (Models S18751VN, S18751VT, S18751EP) is specifically engineered for fluoroscopic and radiographic procedures in vascular, orthopedic, and electrophysiology specialties. The S18751VN model supports general diagnostic imaging, while the S18751VT (TrackVision) variant enhances vascular navigation with real-time tracking, and the S18751EP (EPVision) variant is optimized for electrophysiology interventions. Its integrated segmented DICOM 3D datasets and live fluoroscopy provide precise visualization tailored to each specialty’s unique requirements.
How are the components of the Innova Vision system supplied, and what sterilization protocols apply?
The Innova Vision system is supplied as a standalone X-ray imaging unit with integrated software running on the Advantage Workstation platform. Components may be either single-use or reusable, depending on the manufacturer’s specifications for each part. Imaging components that require reuse must follow approved sterilization protocols to ensure safety and functionality. The manufacturer’s guidelines should be consulted for specific component categorization and sterilization instructions.
Is the Innova Vision system compatible with MRI environments, and what safety measures are required?
The Innova Vision system is explicitly labeled as MRI-unsafe, meaning it should never be used in or near MRI environments due to potential interference or safety hazards. When operating this system, strict adherence to radiation safety standards is mandatory, including proper shielding, dose monitoring, and compliance with local regulatory guidelines for X-ray imaging equipment. Always ensure the facility’s radiation safety protocols are followed.
What distinguishes the S18751VT (TrackVision) model from the other Innova Vision variants?
The S18751VT (TrackVision) model is tailored for vascular procedures, offering enhanced real-time tracking capabilities to assist in navigation during interventions such as stent placements or catheterizations. Unlike the S18751VN (general diagnostic) or S18751EP (electrophysiology) models, TrackVision integrates specialized software and imaging algorithms to improve precision in vascular workflows, reducing procedural risks and improving outcomes.
What storage requirements apply to the Innova Vision system, and how should it be maintained?
The Innova Vision system’s storage requirements align with standard practices for X-ray imaging equipment. The unit should be stored in a clean, dry environment protected from extreme temperatures, humidity, and physical damage. Regular maintenance, including calibration of imaging components and software updates, is essential to ensure optimal performance. Follow the manufacturer’s operational and maintenance manuals for detailed storage and upkeep instructions, particularly for components that may require periodic inspection or replacement.