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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 K173079
Device Name Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan van de Kerkhot
Correspondent
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland,  OH  44143
Correspondent Contact Susan Quick
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received09/29/2017
Decision Date 04/04/2018
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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