Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K951144 |
Device Name |
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS |
Applicant |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1200 |
Classification Product Code |
|
Date Received | 03/13/1995 |
Decision Date | 07/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|