The following data is part of a premarket notification filed by Ramsoft Inc. with the FDA for Omegaai Image Viewer.
| Device ID | K222476 |
| 510k Number | K222476 |
| Device Name: | OmegaAI Image Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | RamSoft Inc. 150 Wheeler Ave Toronto, CA M4L3V4 |
| Contact | Deeksha Shukla |
| Correspondent | Deeksha Shukla RamSoft Inc. 150 Wheeler Ave Toronto, CA M4L3V4 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-11-17 |