510(k) Report

Devices descending from K981533

67 later devices reach Aviva Systems Model Numbers 1010, 2020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051470Remote Care Management Systems (RCMS)Bl Healthcare, Inc.200521—
+1K020584N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd.200252—
+1K012801N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd.200153—
+2K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+2K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+2K083046Fora Telehealth SystemTaidoc Technology Corporation20090—
+2K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies20082—
+2K071564Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems20075—
+2K062662Telemedicine System Model VMS-01Medic4all (Israel), Ltd.20062—
+2K062127MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp)Medic4all (Israel), Ltd.20062—
+2K061502MEDIC4ALL Telemedicine System VMS-01Medic4all (Israel), Ltd.20062—
+2K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc.20065—
+2K033133Telecare D.R. Server Software SystemHealthcare Vision, Inc.20043—
+2K031863Carestation 126S VideophoneMotion Media Technology, Inc.200310—
+2K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+3K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+3K120895Remote Presence SystemIntouch Health, Inc.20121—
+3K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+3K091579Foresee HomeNotal Vision, Ltd.20094—
+3K090801Electronic House CallExpress MD Solutions, LLC20093—
+3K080091Modification to:Health Buddy ApplianceHealth Hero Network, Inc.20081—
+3K061571ASTRA 300Sdi Diagnostics, Inc.20070—
+3K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+4K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+4K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+4K123229Remote Presence System, Model RP-VitaIntouch Health, Inc.20120—
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+4K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+4K063008Health Check KioskXperex Corporation20074—
+4K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+5K233446AMC Health CareConsoleAmc Health20240—
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K151839AMC Health VitalCaregiving SystemAmc Health20161—
+5K143108HealthGuard-15Futrex, Inc.20150—
+5K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+5K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+5K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+5K113402Solohealth StationSolohealth, Inc.20120—
+5K111922Vocare Myhealth TabletVocare, Inc.20110—
+5K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+5K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+5K110334Waldo Patient MonitorWaldo Health20111—
+5K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+5K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+5K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+5K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+5K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+6K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+6K180895AlleyeOculocare Medical AG20181—
+6K153600Consult Station TSH4D Sas20170—
+6K133997LG SmarthealthLg Electronics20140—
+6K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+6K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+6K122333Mobilecare MonitorAframe Digital, Inc.20120—
+6K122285Tablet CommanderCardiocom, LLC20125—
+6K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+6K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+7K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+7K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+7K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+7K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+7K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+7K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—