Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K083224 |
Device Name |
CPI RAD VISION, MODEL VZW2944XX-YY |
Applicant |
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
45 RIVER DRIVE |
GEORGETOWN,ONTARIO,
CA
L7G 2J4
|
|
Applicant Contact |
NORM MORIKAWA |
Correspondent |
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
45 RIVER DRIVE |
GEORGETOWN,ONTARIO,
CA
L7G 2J4
|
|
Correspondent Contact |
NORM MORIKAWA |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 11/03/2008 |
Decision Date | 03/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|