Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K023932 |
Device Name |
GE PHOTON ENERGY RECOVERY (PER) OPTION |
Applicant |
GE MEDICAL SYSTEMS F.I. HAIFA |
4 HAYOZMA ST., P.O. BOX 170 |
TIRAT HACARMEL,
IL
30200
|
|
Applicant Contact |
HEMY NEUMAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 11/26/2002 |
Decision Date | 12/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|