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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 K111142
Device Name ECHOSOFT(TM)
Applicant
Echometrix, LLC
2210 Woodhill Way
Waukesha,  WI  53189
Applicant Contact LARRY A KROGER
Correspondent
Echometrix, LLC
2210 Woodhill Way
Waukesha,  WI  53189
Correspondent Contact LARRY A KROGER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/2011
Decision Date 09/21/2012
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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