Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K970606 |
Device Name |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Applicant |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/18/1997 |
Decision Date | 04/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|