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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 K192109
Device Name KOALA
Applicant
IB Lab GmbH
Hietzinger Hauptstrasse 50/10
Vienna,  AT 1130
Applicant Contact Richard Ljuhar
Correspondent
Hogan Lovells US LLP
555 13th Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received08/05/2019
Decision Date 11/05/2019
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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