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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 K102344
Device Name MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
Applicant
Philips Medical Systems Nederland B.V.
22100 Bothell Everett Hwy.
Bothell,  WA  98041
Applicant Contact LYNN HARMER
Correspondent
Philips Medical Systems Nederland B.V.
22100 Bothell Everett Hwy.
Bothell,  WA  98041
Correspondent Contact LYNN HARMER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/18/2010
Decision Date 11/09/2010
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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