Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K081347 |
Device Name |
ILUMA VISION |
Applicant |
IMTEC CORP. |
2401 NORTH COMMERCE |
ARDMORE,
OK
73401
|
|
Applicant Contact |
BRAD VANCE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/14/2008 |
Decision Date | 05/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|