510(k) Report

Devices descending from K043271

7 later devices reach R2-Mri Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+1K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+1K111222Mri-Q SystemResonance Health Analysis Services Pty, Ltd.20110—
+2K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+2K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+2K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+3K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—