Device Classification Name |
System, X-Ray, Extraoral Source, Digital
|
510(k) Number |
K122155 |
Device Name |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
Applicant |
VATECH CO., LTD. |
12946 KIMBERLEY LN |
HOUSTON,
TX
77079
|
|
Applicant Contact |
DAVE KIM |
Correspondent |
VATECH CO., LTD. |
12946 KIMBERLEY LN |
HOUSTON,
TX
77079
|
|
Correspondent Contact |
DAVE KIM |
Regulation Number | 872.1800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 09/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|