510(k) Report

Devices descending from K160703

55 later devices reach NeuroStar TMS Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics202311
+1K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics202313—
+1K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…Neuronetics, Inc.20220—
+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—
+1K180907HORIZON TMS Therapy SystemMagstim Company, Ltd.2018123
+1K171481MagVita TMS Therapy SystemTonica Elektronik A/S201748—
+1K161519NeuroStar TMS Therapy SystemNeuronetics, Inc.201627—
+2K260691BTL-699BTL Industries, Inc.20260—
+2K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH20260—
+2K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251—
+2K251119MagVenture TMS Therapy SystemTonica Elektronik A/S20253—
+2K243460Ultimate rTMSBrain Ultimate, Inc.20251—
+2K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.202471
+2K232688NQ TMS for MDD (NQv1-MU-01)Neuroqore, Inc.20230—
+2K230735Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc.20231—
+2K231350OCD MT Cap (85-00397-000)Neuronetics20230—
+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—
+2K201158NeuroStar Advanced TherapyNeuronetics, Inc.202024—
+2K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S202024—
+2K183376HORIZON TMS Therapy System with NavigationMagstim Company, Ltd.201972
+2K182853HORIZON TMS Therapy SystemMagstim Company, Ltd.2019102
+2K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S201839—
+2K180313Apollo TMS Therapy SystemMag & More GmbH20184—
+2K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC201717—
+3K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.20260—
+3K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.20260—
+3K260402MeRT SystemWave Neuroscience20260—
+3K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S20260—
+3K251391BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+3K250689CloudTMS EdgeTeleemg, LLC20250—
+3K243700Apollo TMS Therapy SystemMag & More GmbH20251—
+3K243539Apollo TMS Therapy SystemMag & More GmbH20250—
+3K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.20250—
+3K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20251—
+3K243319Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20251—
+3K232639Apollo TMS Therapy SystemMag & More GmbH20243—
+3K233631ZapStim Controller Application (Z1023)Revital Lab, Inc.20240—
+3K230657BTL-99-OCBTL Industries, Inc.20241—
+3K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd.20232—
+3K221129CloudTMS for OCDTeleemg, LLC20231—
+3K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd.20221—
+3K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc.20211—
+3K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Magstim Company, Ltd.20216—
+3K203735Brainsway Deep TMS SystemBrainsway, Ltd.20210—
+3K182700Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc20193—
+4K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—
+4K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.20260—
+4K251210Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20250—
+4K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20241—
+4K233742CloudTMS Edge for OCDTeleemg, LLC20230—
+4K220177Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001KMagnus Medical, Inc.20222—
+5K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—
+5K251449BrainsWay Deep TMS SystemBrainsway, Ltd.20250—