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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 K230972
Device Name Ingenia Elition and MR 7700 MR Systems
Applicant
Philips Medical Systems, Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Ioana Ulea
Correspondent
Philips Medical Systems, Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Correspondent Contact Ioana Ulea
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received04/05/2023
Decision Date 04/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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