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 |