510(k) Report

Devices descending from K935020

60 later devices reach Omni-Trac Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K950264MaglifeOdam199659—
+2K023195Maglife C/Maglife C PlusSchiller Medical S.A.200357—
+2K972535Maglife COdam19980—
+3K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc.200456—
+4K0534623160 Mri Patient Monitoring SystemInvivo Corporation2006532
+4K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.200555—
+5K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+5K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+6K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+6K143503BioMonitorBiotronik, Inc.20159—
+6K132960BiomonitorBiotronik, Inc.201410—
+6K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K122161SJM ConfirmSt Jude Medical20124—
+6K121424Expression Information PortalInvivo Corporation201224
+6K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+7K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+7K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+7K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+7K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+7K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K150614Reveal LINQMedtronic, Inc.201515—
+7K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+7K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+8K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+8K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+8K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+8K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+8K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+8K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+8K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+8K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+8K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+8K160809Reveal LINQMedtronic, Inc.201612—
+8K160689Reveal LINQMedtronic, Inc.20161—
+9K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+9K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+9K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+9K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+9K162855Reveal LINQMedtronic, Inc.2017111
+9K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+10K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+10K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+10K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+11K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+12K230375Biomonitor IVBiotronik, Inc.20231—
+13K261074Biomonitor IV (471155)Biotronik, Inc.20260—