510(k) Report

Devices descending from K993516

336 later devices reach HP M2600A Viridia Telemetry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K121424Expression Information PortalInvivo Corporation201224
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+7K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+7K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K241397HinscopeHinlab Sas20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—