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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
Predetermined Change
Control Plan Authorized		 No
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