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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 K080762
Device Name IB NEURO, VERSION 1.0
Applicant
Imaging Biometrics, LLC
1035 Katherine Dr.
Elm Grove,  WI  53122
Applicant Contact MICHAEL SCHMAINDA
Correspondent
Imaging Biometrics, LLC
1035 Katherine Dr.
Elm Grove,  WI  53122
Correspondent Contact MICHAEL SCHMAINDA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/18/2008
Decision Date 05/15/2008
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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