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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 K101166
Device Name 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
Original Applicant
9900 innovation drive
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.2050
Classification Product Code
Date Received04/26/2010
Decision Date 10/07/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No