Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K070080 |
Device Name |
INTELEPACS |
Applicant |
INTELERAD MEDICAL SYSTEMS INC. |
460 STE-CATHERINE WEST |
SUITE 210 |
MONTREAL QUEBEC,
CA
M3B 1A7
|
|
Applicant Contact |
ANIBAL JODORCOVSKY |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/09/2007 |
Decision Date | 01/24/2007 |
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
|
|
|