FDA-cleared K242488

Soteria E-View

Omega Medical Imaging, LLC

Soteria E-View supports radiographic and fluoroscopic applications, including general and pediatric diagnostic imaging and gastrointestinal or interventional X-ray procedures,...

Modality
Fluoroscopy/Angiography
Anatomy
Gastrointestinal, general, pediatric, and interventional X-ray anatomy
Decision
2025-01-06
FDA-cleared K212336

Soteria.AI

Omega Medical Imaging, LLC

Soteria.AI provides the cleared image-processing support described in K212336 for supported fluoroscopic studies; outputs are reviewed by trained professionals within the labeled...

Modality
Fluoroscopy/Angiography
Anatomy
Fluoroscopic procedure anatomy represented in supported X-ray studies
Decision
2021-11-17