Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K123584 |
Device Name |
SYNGO, CT BONE READING |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
KIMBERLY MANGUM |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
KIMBERLY MANGUM |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/21/2012 |
Decision Date | 03/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|