Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K163703 |
Device Name |
VIVIX-S 1417N |
Applicant |
VIEWORKS CO., LTD. |
(GWANYANG-DONG) 41-3, BURIM-RO 170BEON-GIL, |
ANYANG-SI,
KR
431-060
|
|
Applicant Contact |
JORDIN KIM |
Correspondent |
LK CONSULTING GROUP USA INC. |
800 ROOSEVELT STE 417 |
IRVINE,
CA
92620
|
|
Correspondent Contact |
PRISCILLA CHUNG |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 12/29/2016 |
Decision Date | 02/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|