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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K121513
Device Name MULTIX FUSION
Applicant
Siemens Medical Solution
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact PATRICIA D JONES
Correspondent
Siemens Medical Solution
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact PATRICIA D JONES
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/21/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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