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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 K974530
Device Name DUFFUSION-WEIGHTED MR IMAGING PACKAGE
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact ELAINE K KEELER
Correspondent
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact ELAINE K KEELER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/02/1997
Decision Date 02/06/1998
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
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