Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K062237 |
Device Name |
CADI, VERSION 4 |
Applicant |
SYNCA MARKETING, INC. |
337 MARION STREET |
LE GARDEUR, QUEBEC,
CA
J5Z 4W8
|
|
Applicant Contact |
STEPHANE ARSENAULT |
Correspondent |
SYNCA MARKETING, INC. |
337 MARION STREET |
LE GARDEUR, QUEBEC,
CA
J5Z 4W8
|
|
Correspondent Contact |
STEPHANE ARSENAULT |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/02/2006 |
Decision Date | 11/20/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|