Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K913637 |
Device Name |
ECAT SCANNER (MODEL 921) |
Applicant |
CTI PET SYSTEMS, INC. |
810 INNOVATION DR. |
P.O. BOX 22999 |
KNOXVILLE,
TN
37932 -2562
|
|
Applicant Contact |
DONALD A PERRINE |
Correspondent |
CTI PET SYSTEMS, INC. |
810 INNOVATION DR. |
P.O. BOX 22999 |
KNOXVILLE,
TN
37932 -2562
|
|
Correspondent Contact |
DONALD A PERRINE |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 08/15/1991 |
Decision Date | 11/27/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|