System, Image Processing, Radiological

IB Lab GmbH

The following data is part of a premarket notification filed by Ib Lab Gmbh with the FDA for Koala.

Pre-market Notification Details

Device IDK192109
501k NumberK192109
Device Name:KOALA
ClassificationSystem, Image Processing, Radiological
Applicant IB Lab GmbH Hietzinger Hauptstrasse 50/10 Vienna,  AT 1130
ContactRichard Ljuhar
CorrespondentJohn J Smith
Hogan Lovells US LLP 555 13th Street, NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-05
Decision Date2019-11-05

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