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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 K163116
Device Name Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Ruojuan Zhang
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Ruojuan Zhang
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/07/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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