Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K131634 |
Device Name |
SYMBIA |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932 -2751
|
|
Applicant Contact |
ELAINE CHANG |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932 -2751
|
|
Correspondent Contact |
ELAINE CHANG |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2013 |
Decision Date | 08/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|