Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K040050 |
Device Name |
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 |
Applicant |
GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN |
384 WRIGHT BROTHERS DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
JEFF WAGNER |
Correspondent |
GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN |
384 WRIGHT BROTHERS DRIVE |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
JEFF WAGNER |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/12/2004 |
Decision Date | 03/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|