Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K073056 |
Device Name |
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
Applicant |
VIEWORKS CO., LTD. |
307-2, SANGDAEWON-DONG |
JUNGWON-GU, SEONGNAM-CITY, |
GYEONGGI-DO,
KR
462-806
|
|
Applicant Contact |
KIM RAZA |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
455 E. TRIMBLE ROAD |
SAN JOSE,
CA
95131 -1230
|
|
Correspondent Contact |
MORTEN S CHRISTENSEN |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/30/2007 |
Decision Date | 11/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|