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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K170396
Device Name MAGNETOM Vida
Applicant
Siemens Medical Solutions USA, Inc.
65 Valley Stream Pkwy. Mailcode 65-1a
Malvern,  PA  19355
Applicant Contact Cordell L. Fields, Esq.
Correspondent
Siemens Medical Solutions USA, Inc.
65 Valley Stream Pkwy. Mailcode 65-1a
Malvern,  PA  19355
Correspondent Contact Cordell L. Fields, Esq.
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received02/09/2017
Decision Date 06/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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