510(k) Report

Devices descending from K082228

23 later devices reach Planisight Linasys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+1K113620Myrian 1.11Intrasense20126—
+1K091001Myrian 1.4Intrasense20097—
+2K241543DrAid™ for Liver SegmentationVinbrain Joint Stock Company20240—
+2K183133MRCP+ v1.0Perspectum Diagnostics, Ltd.20191—
+2K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+2K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+2K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K240620Cube NavigatorMedical Templates AG20240—
+3K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+3K211655aPROMISEExini Diagnostics AB20211—
+3K191530StoneCheckerImaging Biometrics, LLC20191—
+3K180867AmCAD-UOAmcad Biomed Corporation20180—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K220590aPROMISE XExini Diagnostics AB20220—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K202084DeepLook PRECISEDeeplook, Inc.20210—
+4K200315Ziostation2Ziosoft, Inc.20200—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K233457RUSHutom, Inc.20240—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—