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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 K223458
Device Name Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6,
Best,  NL 5684PC
Applicant Contact Ioana Ulea
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6,
Best,  NL 5684PC
Correspondent Contact Ioana Ulea
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/16/2022
Decision Date 04/06/2023
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
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