Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K973168 |
Device Name |
SMARTVIEW OPTIONS FOR HISPEED CT/I |
Applicant |
GE MEDICAL SYSTEMS |
16800 RYERSON RD. |
NEW BERLIN,
WI
53151
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
16800 RYERSON RD. |
NEW BERLIN,
WI
53151
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 08/25/1997 |
Decision Date | 11/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|