The following data is part of a premarket notification filed by Oryx Dental Software Inc with the FDA for Oryx Cloud Imaging.
| Device ID | K220684 |
| 510k Number | K220684 |
| Device Name: | Oryx Cloud Imaging |
| Classification | System, Image Processing, Radiological |
| Applicant | Oryx Dental Software INC 1001 Fairview Avenue North Suite 2275 Seattle, WA 98109 |
| Contact | Rania Saleh |
| Correspondent | Mary Vater Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-08 |
| Decision Date | 2022-04-29 |