Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K924310 |
Device Name |
PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC |
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 | 892.2050
|
Classification Product Code |
|
Date Received | 08/26/1992 |
Decision Date | 01/21/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|