Device Classification Name |
X-Ray, Tomography, Computed, Dental
|
510(k) Number |
K102196 |
Device Name |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Applicant |
VATECH CO., LTD. |
333 MEADOWLANDS PARKWAY |
#303 |
SECAUCUS,
NJ
07094
|
|
Applicant Contact |
DAVE KIM |
Correspondent |
VATECH CO., LTD. |
333 MEADOWLANDS PARKWAY |
#303 |
SECAUCUS,
NJ
07094
|
|
Correspondent Contact |
DAVE KIM |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/29/2010 |
Decision Date | 03/25/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|