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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 K901602
Device Name VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
Applicant
Resonex, Inc.
720 Palomar Ave.
Sunnyvale,  CA  94086
Applicant Contact BRUCE FLOYD
Correspondent
Resonex, Inc.
720 Palomar Ave.
Sunnyvale,  CA  94086
Correspondent Contact BRUCE FLOYD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/06/1990
Decision Date 05/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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