510(k) Report

Devices descending from K900598

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+8K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+8K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K170497V10Mediana Co., Ltd.201711
+8K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+8K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+8K153156eCareManager 4.0.1Visicu, Inc.20163—
+8K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+8K152552Patient MonitorEdan Instruments, Inc.201621
+8K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+8K142032Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin20154—
+8K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+8K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+8K130401Alertwatch: orAlertwatch, LLC20148—
+8K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+8K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+8K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+8K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+8K120173Patient MonitorEdan Instruments, Inc.201210—
+8K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K113653Patient MonitorEdan Instruments, Inc.201212
+8K113623Patient MonitorEdan Instruments, Inc.2012152
+8K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+8K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+8K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+8K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+8K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+8K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+8K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+8K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+8K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+8K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc.200726—
+8K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+8K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+8K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+9K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—
+9K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+9K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+9K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+9K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+9K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+9K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+9K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+9K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K220111RespiraSensePmd Solutions20221—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+9K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+9K213515WesperO2Wesper, Inc.20220—
+9K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+9K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+9K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+9K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+9K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+9K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+9K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+9K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+9K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+9K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+9K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+9K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+9K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+9K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+9K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+9K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+9K172226MX40 Release B.07Philips Medical Systems201713—
+9K1722003880 MRI Patient Monitoring SystemIradimed Corporation20172—
+9K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+9K171322eCareManager 4.1Visicu, Inc.20172—
+9K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+9K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+9K160981Patient MonitorEdan Instruments, Inc.201681
+9K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin20160—
+9K153335AlertWatch: ORAlertwatch, LLC20161—
+9K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+9K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+9K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+9K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+9K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+9K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+9K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+9K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc.2013252
+9K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+9K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+9K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416