510(k) Report

Devices descending from K201039

2 later devices reach HepaFat-AI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+1K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—