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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 K013858
Device Name INFINION 0.6T MR IMAGING SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact DUANE C PRASCHAN
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact DUANE C PRASCHAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/21/2001
Decision Date 01/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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