Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K032915 |
Device Name |
ADVANTAGE 4D OPTION |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
W-400 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
JUERGEN WELTE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 09/22/2003 |
Decision Date | 10/30/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|