Soteria E-View
Omega Medical Imaging, LLCThe Soteria E-View is a fluoroscopic and radiographic X-ray imaging system designed for use in general and pediatric populations. It provides real-time imaging during interventional procedures, helping clinicians visualize patient anatomy effectively. It integrates advanced flat panel detector technology and radiation safety controls to reduce exposure while delivering high-quality images for diagnostic and interventional use.
Intended Use
The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.
Technology
The system consists of a patient table, C-arm with X-ray source and flat panel detector, positioner controls, X-ray generator, image processor, and CA-100S / FluoroShield radiation safety accessory. It uses a Varex Azure 3131Z CXP flat panel detector with Indium Gallium Zinc Oxide technology for high quantum efficiency and lower dose. The system supports various acquisition modes such as pulsed fluoroscopy, spot imaging, and storage of reference images. Controls include fluoro, spot, and save buttons integrated in the positioner, with updated electronics and power supplies to comply with safety standards.
Performance
Non-clinical and sample clinical images were used to validate image performance and demonstrate substantial equivalence to the predicate device. Software verification and risk management processes were conducted following IEC 62304 and ISO 14971 standards. Testing confirmed safety, reliability, and effectiveness for intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/21/2024
4 months - 2
FDA Approval
1/6/2025
Other devices from Omega Medical Imaging, LLC
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.