Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K191347 |
Device Name |
Paragon XHD Diagnostic Ultrasound System |
Applicant |
Shenzhen Wisonic Medical Technology Co., Ltd. |
1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, |
Taoyuan Street, Nanshan |
Shenzhen,
CN
518055
|
|
Applicant Contact |
Jiang Xiaosan |
Correspondent |
Shenzhen Wisonic Medical Technology Co., Ltd. |
1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, |
Taoyuan Street, Nanshan |
Shenzhen,
CN
518055
|
|
Correspondent Contact |
Jiang Xiaosan |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/20/2019 |
Decision Date | 02/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|