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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 K183063
Device Name Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan van de Kerkhof
Philips Medical Systems Nederland B.V.
595 Miner Rd
Cleveland,  OH  44143
Correspondent Contact Susan Quick
Regulation Number892.1000
Classification Product Code
Subsequent Product Code
Date Received11/05/2018
Decision Date 02/14/2019
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