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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 K213516
Device Name Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Applicant
Philips Medical Systems Nederland, B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan van de Kerkhof
Correspondent
Philips Medical Systems Nederland, B.V.
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Jan van de Kerkhof
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/03/2021
Decision Date 03/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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