510(k) Report

Devices descending from K981397

403 later devices reach Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+20K260589ES-SeriesE-Scopics20260—
+20K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+20K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—