Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K113342 |
Device Name |
SOMATOM DEFINITION FLASH |
Applicant |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
KIM MANGUM |
Correspondent |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
KIM MANGUM |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 12/29/2011 |
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
|
|
|