Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K936136 |
Device Name |
UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE |
Applicant |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
ROBERT ODELL |
Correspondent |
GE DEC MEDICAL SYSTEMS |
384 WRIGHT BROTHERS DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
ROBERT ODELL |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 12/22/1993 |
Decision Date | 01/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|