Soteria.AI
Omega Medical Imaging, LLCSoteria.AI is an image-intensified fluoroscopic x-ray system designed for use in a variety of radiographic and fluoroscopic applications including cardiac, vascular, general diagnostic, and interventional imaging. It helps reduce patient and operator radiation exposure by automatically providing a region of interest using AI technology, thereby improving safety during imaging procedures.
Intended Use
The System is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging for General and Pediatric Populations.
Technology
The device provides automated Region of Interest using AI (Soteria.AI system) with FluoroShield / CA-100S accessory to reduce exposure to patient and operator in image-intensified fluoroscopic x-ray imaging systems.
Performance
Software verification and non-clinical validation testing were performed to verify system requirement compliance, safety, and effectiveness. Clinical data was not required due to demonstrated substantial equivalence to predicate device Omega CS-series-FP with similar attributes.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/27/2021
3 months - 2
FDA Approval
11/17/2021
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