510(k) Report

Devices descending from K900598

434 later devices reach Tramscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+12K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+12K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+12K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+12K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+12K232915EpiMonitorEmpatica S.r.l.20241—
+12K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+12K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+12K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+12K230842SignalHF (IM008)Implicity, Inc.20230—
+12K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+12K221203AHI SystemFifth Eye, Inc.20220—
+12K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+12K212227Philips MR Patient Care PortalInvivo Corporation202101
+12K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+12K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+12K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+12K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+12K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+13K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+13K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+13K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+13K252981EmbraceMiniEmpatica S.r.l.20251—
+13K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+13K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+13K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+13K212271smart-syncNorthh Medical GmbH20220—
+13K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+13K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—