Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K020929 |
Device Name |
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 |
Applicant |
GE MEDICAL SYSTEMS |
283 RUE DE LA MINIERE |
BP 34 |
BUC CEDEX,
FR
78533
|
|
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
WOLFRAM GMELIN |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/22/2002 |
Decision Date | 04/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|