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 |