Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K110332 |
Device Name |
CLEARCANVAS RIS / PACS |
Applicant |
CLEARCANVAS INC. |
439 UNIVERSITY AVE. |
SUITE 1920 |
TORONTO, ON,
CA
M5G 1Y8
|
|
Applicant Contact |
CLINTON CHAU |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAULA WILKERSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/03/2011 |
Decision Date | 03/24/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|