510(k) Report

Devices descending from K121213

8 later devices reach Vitreaadvanced through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+1K153289HealthmyneHealthmyne, Inc.20160—
+1K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+2K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+4K233457RUSHutom, Inc.20240—
+5K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—