Soteria E-View

The Soteria E-View is an interventional fluoroscopic X-ray system intended for radiographic and fluoroscopic diagnostic imaging and interventional procedures in general and pediatric populations. It includes a C-arm with X-ray source, flat panel detector, patient table, image processor, and the FDA-cleared CA-100S/FluoroShield accessory for automated region-of-interest dose reduction.

The Soteria E-View replaces the predicate's Teledyne Dalsa CMOS detector with a Varex Azure 3131Z IGZO detector offering slightly higher resolution (3.3 vs 3.15 lp/mm) and lower dose characteristics. The X-ray generator changed from 80KV to GI Epsilon, the positioner from L/C to I/C configuration, and the patient table became a shorter GI-specific design supporting 800 pounds. Cine mode and cardiac/vascular filtering were removed from the indications for use.

IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 60601-2-54 and IEC 60601-2-43 (X-ray safety standards), EN 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-1-6, EN ISO 15223-1, UL 60601-1, and 21 CFR Parts 1020.30-1020.32 (Federal Diagnostic X-ray Equipment Standards).

The Soteria E-View maintains the same indications for use, intended patient population, and fundamental imaging functionality as the predicate Soteria.AI. Although component changes were made (detector type, generator, table design, removal of cardiac/vascular features), these changes do not introduce new safety or effectiveness concerns because the IGZO detector provides equivalent or superior image quality at lower dose, the positioner and table movements remain functionally similar, and the system retains the same integrated FluoroShield radiation safety controls. Non-clinical and sample clinical testing demonstrated conformance to the intended use and performance claims.