Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K003264 |
Device Name |
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION |
Applicant |
GE MEDICAL SYSTEMS F.I. HAIFA |
10 HAYOZMA ST., P.O. BOX 170 |
TIRAT HACARMEL,
IL
30200
|
|
Applicant Contact |
DAN LAOR |
Correspondent |
GE MEDICAL SYSTEMS F.I. HAIFA |
10 HAYOZMA ST., P.O. BOX 170 |
TIRAT HACARMEL,
IL
30200
|
|
Correspondent Contact |
DAN LAOR |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 10/18/2000 |
Decision Date | 12/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|