KOALA

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 ID: K192109
• 510k Number: K192109
• Device Name: KOALA
• Classification: System, Image Processing, Radiological
• Applicant: IB Lab GmbH Hietzinger Hauptstrasse 50/10 Vienna, AT 1130
• Contact: Richard Ljuhar
• Correspondent: John J Smith; Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-05
• Decision Date: 2019-11-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09120105730082	K192109	000
09120105730471	K192109	000
09120105730464	K192109	000