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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 K003853
Device Name INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact DUANE PRASCHAN
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact DUANE PRASCHAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/12/2000
Decision Date 02/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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