Device Classification Name |
system, x-ray, angiographic
|
510(k) Number |
K221711 |
Device Name |
AccuICAS |
Applicant |
ArteryFlow Technology Co., Ltd. |
459 Qianmo Road, Suite C1-501, Binjiang District, |
Hangzhou,
CN
310051
|
|
Applicant Contact |
Jianping Xiang |
Correspondent |
ArteryFlow Technology Co., Ltd. |
459 Qianmo Road, Suite C1-501, Binjiang District, |
Hangzhou,
CN
310051
|
|
Correspondent Contact |
Ashley Fu |
Regulation Number | 892.1600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/13/2022 |
Decision Date | 02/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|