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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
IB Lab GmbH
Hietzinger Hauptstrasse 50/10
Vienna,  AT 1130
Applicant Contact Richard Ljuhar
Hogan Lovells US LLP
555 13th Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2050
Classification Product Code
Subsequent Product Code
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