Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K022310 |
Device Name |
ADVANTAGE WINDOWS X-RAY/MR FUSION |
Applicant |
GE MEDICAL SYSTEMS, INC. |
3000 N. GRANDVIEW BLVD. |
waukesha,
WI
53188
|
|
Applicant Contact |
larry kroger |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
newton,
CT
06470
|
|
Correspondent Contact |
wolfram gmelin |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/17/2002 |
Decision Date | 08/01/2002 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|