Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K153244 |
Device Name |
Cios Fusion |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
40 LIBERTY BOULEVARD 65-1A |
MALVERN,
PA
19355
|
|
Applicant Contact |
DARREN A. DORMAN |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
40 LIBERTY BOULEVARD 65-1A |
MALVERN,
PA
19355
|
|
Correspondent Contact |
Patricia Jones |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/09/2015 |
Decision Date | 03/07/2016 |
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
|
|
|