Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K151075 |
Device Name |
BR-ABVS Viewer 1.0 |
Applicant |
TAIHAO MEDICAL INC. |
7F., NO.410, SEC.5M ZHONGXIAO E. RD., XINYI DIST. |
taipei,
TW
|
|
Applicant Contact |
hsin hung(simon) lai |
Correspondent |
LIN & ASSOCIATES, LLC |
9223 CAMBRIDGE MANOR COURT |
potomac,
MD
20854
|
|
Correspondent Contact |
chiu s lin |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/22/2015 |
Decision Date | 01/15/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|