Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K162971 |
Device Name |
Multix Fusion Max |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
40 LIBERTY BOULEVARD, MAIL CODE 65-1A |
MALVERN,
PA
19355
|
|
Applicant Contact |
DENISE ADAMS |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
40 LIBERTY BOULEVARD, MAIL CODE 65-1A |
MALVERN,
PA
19355
|
|
Correspondent Contact |
DENISE ADAMS |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/25/2016 |
Decision Date | 11/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|