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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 K061255
Device Name BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
Applicant
KYRON CLINICAL IMAGING, INC.
2457 N. MAYFAIR RD., SUITE 202
WAUWATOSA,  WI  53226
Applicant Contact JAMES L REUSS
Correspondent
KYRON CLINICAL IMAGING, INC.
2457 N. MAYFAIR RD., SUITE 202
WAUWATOSA,  WI  53226
Correspondent Contact JAMES L REUSS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/04/2006
Decision Date 06/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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