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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 K153324
Device Name Ingenia 1.5T and Ingenia 1.5T S R5.2
Applicant
PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
VEENPLUIS 4-6
BEST,  NL 5684 PC
Applicant Contact Henrie Daniels
Correspondent
PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
VEENPLUIS 4-6
BEST,  NL 5684 PC
Correspondent Contact Henrie Daniels
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/18/2015
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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