510(k) Report

Devices descending from K210201

22 later devices reach Deep Transcranial Magnetic Stimulation (DTMS) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222196Deep TMS SystemBrainsway, Ltd.20242—
+1K220819BrainsWay Deep TMS SystemBrainsway, Ltd.20222—
+1K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Neuronetics, Inc.202216—
+2K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH20260—
+2K251391BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+2K251449BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+2K243319Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20251—
+2K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics202311
+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—
+2K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…Neuronetics, Inc.20220—
+3K260691BTL-699BTL Industries, Inc.20260—
+3K251119MagVenture TMS Therapy SystemTonica Elektronik A/S20253—
+3K251210Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20250—
+3K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.202471
+3K231350OCD MT Cap (85-00397-000)Neuronetics20230—
+4K260402MeRT SystemWave Neuroscience20260—
+4K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S20260—
+4K243700Apollo TMS Therapy SystemMag & More GmbH20251—
+4K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251—
+4K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20251—
+5K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—