510(k) Report

Devices descending from K990727

68 later devices reach Syneflash & Syneview through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+1K032466SpiderviewEla Medical, Inc.200356—
+1K031466Iqmark Digital HolterBrentwood Medical Technology Corp.20036—
+2K193177CER-SCardiocalm20202—
+2K142693ZywieAI Software LibraryZywie, Inc.20150—
+2K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141—
+2K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp.20103—
+2K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073—
+2K062088Premier 11 HolterDiagnostic Monitoring Software20060—
+2K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+2K042108Vista PlusNovacor200546—
+3K213861CER-SCardiocalm Srl20221—
+3K181658MobileECG 2 BTMemtec Corporation20190—
+3K182030Faros MobileBittium Biosignals, Ltd.20180—
+3K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma20091—
+3K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical20072—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+4K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+4K243312CER-SCardiocalm Srl20250—
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+4K143503BioMonitorBiotronik, Inc.20159—
+4K142352CardiacLinxRoss Medical Technology, Inc.20150—
+4K132960BiomonitorBiotronik, Inc.201410—
+4K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+4K122161SJM ConfirmSt Jude Medical20124—
+4K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+4K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical20090—
+4K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+5K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+5K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+5K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+5K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+5K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+5K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+5K150614Reveal LINQMedtronic, Inc.201515—
+5K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+5K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+6K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+6K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+6K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+6K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+6K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+6K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+6K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+6K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+6K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+6K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+6K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+6K160809Reveal LINQMedtronic, Inc.201612—
+6K160689Reveal LINQMedtronic, Inc.20161—
+7K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+7K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+7K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+7K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+7K162855Reveal LINQMedtronic, Inc.2017111
+7K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+8K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+8K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+8K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+9K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+10K230375Biomonitor IVBiotronik, Inc.20231—
+11K261074Biomonitor IV (471155)Biotronik, Inc.20260—