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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 K251397
Device Name Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Applicant
Philips Medical Systems Nederland BV
Veenpluis 6
5684 Pc
Best,  NL
Applicant Contact Liselotte Kornmann
Correspondent
Philips Medical Systems Nederland BV
Veenpluis 6
5684 Pc
Best,  NL
Correspondent Contact Liselotte Kornmann
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received05/06/2025
Decision Date 06/04/2025
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
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