The following data is part of a premarket notification filed by Vinbrain Joint Stock Company with the FDA for Draid For Radiology V1.
| Device ID | K221241 |
| 510k Number | K221241 |
| Device Name: | DrAid For Radiology V1 |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area Viet Hung Ward, Long Bien District, VN |
| Contact | Nguyen Nhat Linh |
| Correspondent | Nguyen Nhat Linh VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area Viet Hung Ward, Long Bien District, VN |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-09-01 |