510(k) Report

Devices descending from K192109

6 later devices reach KOALA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241696Ortho AIOrtho Ai, LLC20250—
+1K223621DeepXrayAlpha Intelligence Manifolds, Inc.20231—
+1K223646IB Lab LAMAIb Lab GmbH20231—
+1K203696RBkneeRadiobotics Aps20212—
+2K253172MediAI-OACrescom Co., Ltd.20260—
+2K241593BoneMetrics (US)Gleamer Sas20250—