The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Soteria.ai.
| Device ID | K212336 |
| 510k Number | K212336 |
| Device Name: | Soteria.AI |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford, FL 32771 |
| Contact | John Newman |
| Correspondent | John Newman Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford, FL 32771 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-27 |
| Decision Date | 2021-11-17 |