Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K052434 |
Device Name |
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
Applicant |
GE MEDICAL SYSTEMS |
4 HAYOZMA ST. P.O. BOX 170 |
tirat hacarmel,
IL
30200
|
|
Applicant Contact |
eli werner |
Correspondent |
GE MEDICAL SYSTEMS |
4 HAYOZMA ST. P.O. BOX 170 |
tirat hacarmel,
IL
30200
|
|
Correspondent Contact |
eli werner |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 09/06/2005 |
Decision Date | 09/27/2005 |
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
|
|
|