Radiology
Soteria.AI
Omega Medical Imaging, LLC
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K212336
- Decision date
- November 2021
- FDA panel
- Radiology
- Product code
- OWB
- Clinical task (npj)
- image enhancement
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.