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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 K041602
Device Name PANORAMA 1.0T
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Applicant Contact JOSEPH S ARNAUDO
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Correspondent Contact JOSEPH S ARNAUDO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/14/2004
Decision Date 07/26/2004
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
Recalls CDRH Recalls
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