The following data is part of a premarket notification filed by Medo.ai with the FDA for Medo Aria.
| Device ID | K200356 |
| 510k Number | K200356 |
| Device Name: | MEDO ARIA |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Medo.ai 4560 TEC Centre, 10230 Jasper Avenue Edmonton, CA T5j4p6 |
| Contact | Dornoosh Zonoobi |
| Correspondent | Dornoosh Zonoobi Medo.ai 32 Carpenter Street SG 059911 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-13 |
| Decision Date | 2020-06-11 |