510(k) Report

Devices descending from K122035

3 later devices reach Hepafat Scan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+1K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+2K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—