510(k) Report

Devices descending from K091001

7 later devices reach Myrian 1.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113620Myrian 1.11Intrasense20126—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K181892Ziostation2Ziosoft, Inc.20181—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K200315Ziostation2Ziosoft, Inc.20200—