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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 K063559
Device Name ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
Applicant
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
BOTHELL,  WA  98021 -8431
Applicant Contact JOSEPH S ARNAUDO
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/27/2006
Decision Date 01/04/2007
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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