Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K050509 |
Device Name |
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I |
Applicant |
CTI PET SYSTEMS, INC. |
810 INNOVATION DR. |
KNOXVILLE,
TN
37932 -2571
|
|
Applicant Contact |
ALAINE MEDIO |
Correspondent |
CTI PET SYSTEMS, INC. |
810 INNOVATION DR. |
KNOXVILLE,
TN
37932 -2571
|
|
Correspondent Contact |
ALAINE MEDIO |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2005 |
Decision Date | 03/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|