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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 K133526
Device Name MDIXON-QUANT
Applicant
Philips Medical Systems Nederland B.V.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact SUSAN QUICK
Correspondent
Philips Medical Systems Nederland B.V.
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact SUSAN QUICK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/15/2013
Decision Date 02/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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