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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 K223442
Device Name MR 5300 and MR 7700 R11 MR Systems
Applicant
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684 PC
Applicant Contact Susan Quick
Correspondent
Philips Medical Systems Nederlands B.V.
Veenpluis 6
Best,  NL 5684 PC
Correspondent Contact Susan Quick
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/14/2022
Decision Date 12/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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