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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K123302
Device Name IB CLINIC
Applicant
Imaging Biometrics, LLC
13416 Watertown Plank Rd. Suite 260
Elm Grove,  WI  53122
Applicant Contact MIKE SCHMAINDA
Correspondent
Imaging Biometrics, LLC
13416 Watertown Plank Rd. Suite 260
Elm Grove,  WI  53122
Correspondent Contact MIKE SCHMAINDA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/23/2012
Decision Date 01/11/2013
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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