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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 K052013
Device Name ACHIEVA 1.5T & INERA 1.5T FAMILY
Applicant
Philips Medical Systems Nederland B.V.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact LYNN T HARMER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/26/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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