510(k) Report

Devices descending from K900598

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+9K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+9K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+9K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+9K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+9K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+9K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+10K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+10K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+10K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+10K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+10K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+10K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+10K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+10K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+10K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+10K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K211046eCareManager 4.5Visicu, Inc.20220—
+10K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+10K210160AlertWatch:ACAlertwatch, Inc.20210—
+10K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+10K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+10K200859Infinity M300Draeger Medical Systems, Inc.202021
+10K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+10K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+10K192514Patient MonitorEdan Instruments, Inc.202061
+10K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+10K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+10K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+10K180017MX40 Release C.01Philips Medical Systems20181—
+10K173715AlertWatch:OBAlertwatch, Inc.20180—
+10K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+10K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+10K161056Telemetry TransmitterEdan Instruments, Inc.201702
+10K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+10K151860Infinity CentralStation WideDraeger Medical Systems, Inc.2015232
+10K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+10K131032Philips Suresigns CentralPhilips Medical Systems20131—
+10K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+10K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+10K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+10K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+11K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+11K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+11K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+11K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+11K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+11K241397HinscopeHinlab Sas20240—
+11K240756Aitrics-VCAitrics Co., Ltd.20240—
+11K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+11K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+11K233216CLEWICU SystemClew Medical, Ltd.20240—
+11K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+11K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+11K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+11K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+11K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+11K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+11K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+11K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+11K222550Current Health SystemCurrent Health, Ltd.20221—
+11K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+11K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+11K212219AHI SystemFifth Eye, Inc.20211—
+11K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+11K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+11K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+11K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+11K202336Patient MonitorEdan Instruments, Inc.202131
+11K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+11K192595ExSpiron 2XiRespiratory Motion20190—
+11K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+11K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+11K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+11K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+11K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+11K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+11K121424Expression Information PortalInvivo Corporation201224
+11K103700Essential Mri Patient MonitorInvivo Corporation20110—
+12K260008Deterioration Index Version 2Epic Systems Corporation20260—
+12K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+12K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+12K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+12K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—