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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 K193215
Device Name Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Applicant
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan Van de Kerkhof
Correspondent
Philips Medical Systems Nederland B.V.
595 Miner Rd
Cleveland,  OH  44143
Correspondent Contact Susan Quick
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/21/2019
Decision Date 04/10/2020
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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