Device Classification Name |
X-Ray, Tomography, Computed, Dental
|
510(k) Number |
K090467 |
Device Name |
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D |
Applicant |
VATECH CO., LTD. |
256 NORTH SAM HOUSTON PKWY E. |
SUITE 115 |
HOUSTON,
TX
77060
|
|
Applicant Contact |
VINCENT LEE |
Correspondent |
VATECH CO., LTD. |
256 NORTH SAM HOUSTON PKWY E. |
SUITE 115 |
HOUSTON,
TX
77060
|
|
Correspondent Contact |
VINCENT LEE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/23/2009 |
Decision Date | 01/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|