FDA-cleared K191713
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2019-10-04
Vendor
Omega Medical Imaging, LLC
3 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K212336
Soteria.AI
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2021-11-17
FDA-cleared K242488
Soteria E-View
Omega Medical Imaging, LLC
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-01-06