510(k) Report

Devices descending from K961969

8 later devices reach Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043271R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd.20057—
+2K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+2K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+2K111222Mri-Q SystemResonance Health Analysis Services Pty, Ltd.20110—
+3K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+3K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+3K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+4K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—