510(k) Report

Devices descending from DEN070003

85 later devices reach Neurostar TMS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc.202216—
+1K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc.202219—
+1K133408Neurostar TMS Therapy SystemNeuronetics201477—
+1K130233Neurostar TMS Therapy SystemNeuronetics201378—
+1K122288Brainsway Deep TMS SystemBrainsway, Ltd.201325—
+1K083538Neurostar TMS Therapy System, Model 1.1Neuronetics2008841
+2K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH20260—
+2K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics202311
+2K231350OCD MT Cap (85-00397-000)Neuronetics20230—
+2K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics202313—
+2K223154Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd.20230—
+2K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd.20234—
+2K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…Neuronetics, Inc.20220—
+2K210201Deep Transcranial Magnetic Stimulation (DTMS) SystemBrainsway, Ltd.202122—
+2K203735Brainsway Deep TMS SystemBrainsway, Ltd.20210—
+2K173540Brainsway Deep (DTMS) SystemBrainsway, Ltd.201824—
+2K161519NeuroStar TMS Therapy SystemNeuronetics, Inc.201627—
+2K160703NeuroStar TMS Therapy SystemNeuronetics, Inc.201655—
+2K150641MagVita TMS Therapy SystemTonica Elektronik A/S201557—
+2K143531Rapid Therapy SystemMagstim Company Limited2015623
+3K260691BTL-699BTL Industries, Inc.20260—
+3K243539Apollo TMS Therapy SystemMag & More GmbH20250—
+3K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251—
+3K251119MagVenture TMS Therapy SystemTonica Elektronik A/S20253—
+3K252032T65 (9016E061-)Tonica Elektronik A/S20250—
+3K222196Deep TMS SystemBrainsway, Ltd.20242—
+3K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.202471
+3K232688NQ TMS for MDD (NQv1-MU-01)Neuroqore, Inc.20230—
+3K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd.20232—
+3K230735Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc.20231—
+3K220819BrainsWay Deep TMS SystemBrainsway, Ltd.20222—
+3K212723BTL-995-rTMSBTL Industries, Inc.20221—
+3K202537ALTMS Magnetic Stimulation Therapy SystemRemed Co., Ltd.20212—
+3K201158NeuroStar Advanced TherapyNeuronetics, Inc.202024—
+3K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S202024—
+3K182768TMS-Cobot TS MVAxilum Robotics20191—
+3K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S201839—
+3K180907HORIZON TMS Therapy SystemMagstim Company, Ltd.2018123
+3K180313Apollo TMS Therapy SystemMag & More GmbH20184—
+3K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc201713—
+3K171051HORIZON Therapy SystemMagstim Company, Ltd.201713—
+3K171967MagVita TMS Therapy SystemTonica Elektronik A/S201740—
+3K171481MagVita TMS Therapy SystemTonica Elektronik A/S201748—
+3K170114MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S201741—
+3K162935Rapid2 Therapy SystemMagstim Company, Ltd.2017153
+3K160309Neurosoft TMSTeleemg, LLC201646—
+4K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.20260—
+4K261471Zeta TMS Navigation SystemZeta Surgical, Inc.20260—
+4K260402MeRT SystemWave Neuroscience20260—
+4K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S20260—
+4K251391BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+4K250689CloudTMS EdgeTeleemg, LLC20250—
+4K251449BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+4K243700Apollo TMS Therapy SystemMag & More GmbH20251—
+4K243460Ultimate rTMSBrain Ultimate, Inc.20251—
+4K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.20250—
+4K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20251—
+4K243319Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20251—
+4K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20241—
+4K232639Apollo TMS Therapy SystemMag & More GmbH20243—
+4K230657BTL-99-OCBTL Industries, Inc.20241—
+4K223577Localite TMS Navigator TSLocalite GmbH20232—
+4K221129CloudTMS for OCDTeleemg, LLC20231—
+4K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd.20221—
+4K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc.20211—
+4K191422Neural NavigatorSoterix Medical, Inc.20208—
+4K183376HORIZON TMS Therapy System with NavigationMagstim Company, Ltd.201972
+4K182700Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc20193—
+4K182853HORIZON TMS Therapy SystemMagstim Company, Ltd.2019102
+4K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC201717—
+4K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S201740—
+5K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.20260—
+5K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—
+5K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—
+5K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.20260—
+5K251927Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc.20251—
+5K251210Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20250—
+5K233631ZapStim Controller Application (Z1023)Revital Lab, Inc.20240—
+5K233742CloudTMS Edge for OCDTeleemg, LLC20230—
+5K221544MagVenture TMS Atlas Neuro Navigation SystemTonica Elektronik A/S20230—
+5K220177Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001KMagnus Medical, Inc.20222—
+5K210109visor2 systemEemagine Medical Imaging Solutions GmbH20221—
+5K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Magstim Company, Ltd.20216—
+5K201035ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc.20201—
+6K230089ETHICON LINX® Esophagus Sizing ToolTorax Medical, Inc.20230—