The following data is part of a premarket notification filed by Medo Dx Pte. Ltd. with the FDA for Medo-thyroid.
Device ID | K203502 |
510k Number | K203502 |
Device Name: | MEDO-Thyroid |
Classification | Automated Radiological Image Processing Software |
Applicant | MEDO DX Pte. Ltd. 4560 TEC Centre, 10230 Jasper Avenue Edmonton, CA T5j4p6 |
Contact | Dornoosh Zonoobi |
Correspondent | Dornoosh Zonoobi MEDO DX Pte. Ltd. 4560 TEC Centre, 10230 Jasper Avenue Edmonton, CA T5j4p6 |
Product Code | QIH |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-30 |
Decision Date | 2021-04-23 |