Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K241543 |
Device Name |
DrAid™ for Liver Segmentation |
Applicant |
VinBrain Joint Stock Company |
No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological |
Urban Area, Long Bien District, Hanoi |
Hanoi,
VN
100000
|
|
Applicant Contact |
Steven Quoc Hung Truong |
Correspondent |
VinBrain Joint Stock Company |
No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological |
Urban Area, Long Bien District |
Hanoi,
VN
100000
|
|
Correspondent Contact |
Steven Quoc Hung Truong |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/31/2024 |
Decision Date | 12/06/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|