Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K024137 |
Device Name |
JUPITER PROCESSING AND REVIEW WORKSTATION |
Applicant |
GE MEDICAL SYSTEMS, INC. |
3000 N. GRANDVIEW BLVD. |
waukesha,
WI
53188
|
|
Applicant Contact |
larry a kroger |
Correspondent |
GE MEDICAL SYSTEMS, INC. |
3000 N. GRANDVIEW BLVD. |
waukesha,
WI
53188
|
|
Correspondent Contact |
larry a kroger |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/16/2002 |
Decision Date | 01/15/2003 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|