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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 HIGHWAY
P.O. BOX 3003
BOTHELL,  WA  98041 -8431
Applicant Contact LYNN T HARMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
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
Recalls CDRH Recalls
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