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 |