510(k) clearances for Transcranial Magnetic Stimulator
66 on file
- Tonica Elektronik A/SMay 22, 2026
K260189 · MagVenture Accelerated TMS (aTMS) Therapy System
- Mag & More GmbHMay 22, 2026
K260560 · Apollo TMS Therapy System;Apollo light TMS Therapy System
- Nexstim OyjMar 20, 2026
K253098 · Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- Nexstim OyjMar 20, 2026
K252358 · Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- Soterix Medical, Inc.Feb 20, 2026
K251653 · SPRY TMS Therapy System (0550)
- Brainsway , Ltd.Nov 7, 2025
K251391 · BrainsWay Deep TMS System
- Teleemg, LLCSep 14, 2025
K250689 · CloudTMS Edge
- Brainsway , Ltd.Sep 13, 2025
K251449 · BrainsWay Deep TMS System
- Mag & More GmbHSep 4, 2025
K243700 · Apollo TMS Therapy System
- Mag & More GmbHAug 18, 2025
K243539 · Apollo TMS Therapy System
- Tonica Elektronik A/SAug 11, 2025
K251125 · MagVenture TMS Therapy System
- Tonica Elektronik A/SAug 8, 2025
K251119 · MagVenture TMS Therapy System
- Tonica Elektronik A/SJul 30, 2025
K252032 · T65 (9016E061-)
- Neuromodulatory Devices & ApplicationsJun 27, 2025
K251210 · Ampa One System (AMPA-001)
- Brain Ultimate, Inc.Apr 17, 2025
K243460 · Ultimate rTMS
- The Magstim Company LimitedMar 17, 2025
K243869 · Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
- Neuromodulatory Devices & ApplicationsFeb 13, 2025
K243319 · Ampa One System (AMPA-001)
- The Magstim Company LimitedAug 30, 2024
K241518 · Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
- Brainsway , Ltd.May 31, 2024
K222196 · Deep TMS System
- Mag & More GmbHMay 24, 2024
K232639 · Apollo TMS Therapy System
- Neuronetics, Inc.Mar 22, 2024
K231926 · NeuroStar Advanced Therapy System (All previously cleared models)
- Revital Lab, Inc.Feb 9, 2024
K233631 · ZapStim Controller Application (Z1023)
- Neuroqore, Inc.Dec 29, 2023
K232688 · NQ TMS for MDD (NQv1-MU-01)
- NeuroneticsDec 13, 2023
K233621 · NeuroStar Advanced Therapy System (Version 3.8)
- The Magstim Company , Ltd.Oct 25, 2023
K232235 · Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
- Brain Ultimate, Inc.Sep 13, 2023
K230735 · Ultimate rTMS; Yingchi rTMS
- NeuroneticsApr 4, 2023
K230029 · NeuroStar Advanced Therapy System (Version 3.7)
- Magstim Company, Ltd.Mar 16, 2023
K223154 · Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- Magstim Company, Ltd.Jan 13, 2023
K222171 · Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- Magnus Medical, Inc.Sep 1, 2022
K220177 · Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
- Brainsway , Ltd.Aug 26, 2022
K220819 · BrainsWay Deep TMS System
- Neuronetics, Inc.Aug 24, 2022
K222230 · NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
- Neuronetics, Inc.Jul 15, 2022
K220127 · NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- Remed Co., Ltd.Apr 6, 2022
K220625 · ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
- BTL Industries, Inc.Mar 4, 2022
K212723 · BTL-995-rTMS
- Neuronetics, Inc.Dec 10, 2021
K213543 · NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- Remed Co., Ltd.Nov 26, 2021
K202537 · ALTMS Magnetic Stimulation Therapy System
- Magstim Company, Ltd.Sep 14, 2021
K211389 · Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
- Brainsway , Ltd.Aug 17, 2021
K210201 · Deep Transcranial Magnetic Stimulation (DTMS) System
- Brainsway , Ltd.Apr 23, 2021
K203735 · Brainsway Deep TMS System
- Neuronetics, Inc.Nov 20, 2020
K201158 · NeuroStar Advanced Therapy
- Magstim Company, Ltd.Apr 3, 2019
K183376 · HORIZON TMS Therapy System with Navigation
- Nexstim PlcMar 22, 2019
K182700 · Nexstim Navigated Brain Therapy (NBT) System 2
- Magstim Company, Ltd.Mar 15, 2019
K182853 · HORIZON TMS Therapy System
- Tonica Elektronik A/SAug 14, 2018
K173620 · Mag Vita TMS Therapy System w/Theta Burst Stimulation
- Magstim Company, Ltd.Aug 3, 2018
K180907 · HORIZON TMS Therapy System
- Mag & More GmbHMay 4, 2018
K180313 · Apollo TMS Therapy System
- Brainsway , Ltd.May 3, 2018
K173540 · Brainsway Deep (DTMS) System
- Teleemg, LLCDec 13, 2017
K173441 · Neurosoft TMS (also CloudTMS)
- Nexstim PlcNov 10, 2017
K171902 · Nexstim Navigated Brain Therapy (NBT) System 2
- Tonica Elektronik A/SOct 5, 2017
K172667 · MagVita TMS Therapy w/MagPro R20
- Magstim Company, Ltd.Sep 13, 2017
K171051 · HORIZON Therapy System
- Tonica Elektronik A/SJul 25, 2017
K171967 · MagVita TMS Therapy System
- Tonica Elektronik A/SJun 16, 2017
K171481 · MagVita TMS Therapy System
- Tonica Elektronik A/SMay 1, 2017
K170114 · MagVita TMS Therapy - w/MagPro R20
- Magstim Company, Ltd.Mar 10, 2017
K162935 · Rapid2 Therapy System
- Teleemg, LLCDec 22, 2016
K160309 · Neurosoft TMS
- Neuronetics, Inc.Sep 11, 2016
K161519 · NeuroStar TMS Therapy System
- Neuronetics, Inc.Jun 10, 2016
K160703 · NeuroStar TMS Therapy System
- Tonica Elektronik A/SJul 31, 2015
K150641 · MagVita TMS Therapy System
- Magstim Company LimitedMay 8, 2015
K143531 · Rapid Therapy System
- NeuroneticsMar 28, 2014
K133408 · NEUROSTAR TMS THERAPY SYSTEM
- NeuroneticsApr 30, 2013
K130233 · NEUROSTAR TMS THERAPY SYSTEM
- Brainsway , Ltd.Jan 7, 2013
K122288 · BRAINSWAY DEEP TMS SYSTEM
- NeuroneticsDec 16, 2008
K083538 · NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
- NeuroneticsOct 7, 2008
DEN070003 · NEUROSTAR TMS SYSTEM