510(k) Report

Devices descending from K874685

94 later devices reach Trans-Scan 3-D Transcranial Doppler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991054Bravo Multi-Modality SystemNicolet Biomedical, Inc.1999934
+2K142064Galileo NTEb Neuro S.P.A.20152—
+2K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+2K112052Carefusion Nicolet EdxCarefusion 209, Inc.201230—
+2K082886Zoom-100DCBrainscope Company, Inc.200911—
+2K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+2K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+2K051825CognitraceEemagine Medical Imaging Solutions GmbH20050—
+2K031510Nim-SpineMedtronic Xomed200340—
+2K020218Snap Eeg MonitorNicolet Biomedical, Inc.20021—
+3K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.20240—
+3K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.20240—
+3K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+3K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+3K192572CNS EnvisionMoberg Research, Inc.20190—
+3K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181—
+3K173366NicoletOneNatus Neurology Incorporated20183—
+3K171781eVox SystemEvoke Neuroscience, Inc.20176—
+3K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.201712—
+3K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+3K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+3K131944IEEGJordan Neuroscience, Inc.20140—
+3K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+3K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+3K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+3K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+3K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+3K083124NIM 3.0Medtronic Xomed, Inc.2009303
+3K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc.20082—
+3K060997Snap II Eeg MonitorEverest Biomedical Instruments Co.20060—
+4K251881HippoMind (v1.0)Hippoclinic20250—
+4K243982Nicolet EDXNatus Neurology Incorporated20250—
+4K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+4K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+4K213299Wireless EEG SystemPascall Systems, Inc.20222—
+4K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+4K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+4K192753NeuralScan SystemMedeia, Inc.20203—
+4K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+4K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,20190—
+4K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+4K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+4K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+4K172743Natus VikingQuestNatus Neurology Incorporated20170—
+4K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+4K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+4K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+4K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+4K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+4K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+4K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+4K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+4K092729Baxano Neuro Check DeviceBaxano, Inc.20091—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+5K253767UB ERP SystemUniversal Brain20260—
+5K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+5K221959Q21Neurofield, Inc.20230—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+5K192549Byteflies KitByteflies NV20201—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K173526SENTIO MMG Gen 2Medos International SARL20182—
+5K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+5K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+5K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+6K251550NX01 (NX01)Naox Technologies Sas20250—
+6K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+6K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K223254C2 XploreInomed Medizintechnik GmbH20230—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+7K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—