510(k) Report

Devices descending from K183303

25 later devices reach Brainsway Deep TMS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S202024—
+2K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.20250—
+2K230657BTL-99-OCBTL Industries, Inc.20241—
+2K221129CloudTMS for OCDTeleemg, LLC20231—
+2K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc.202219—
+3K260691BTL-699BTL Industries, Inc.20260—
+3K233742CloudTMS Edge for OCDTeleemg, LLC20230—
+3K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics202311
+3K231350OCD MT Cap (85-00397-000)Neuronetics20230—
+3K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics202313—
+3K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd.20234—
+4K243539Apollo TMS Therapy SystemMag & More GmbH20250—
+4K251119MagVenture TMS Therapy SystemTonica Elektronik A/S20253—
+4K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.202471
+4K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd.20232—
+5K260402MeRT SystemWave Neuroscience20260—
+5K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S20260—
+5K251391BrainsWay Deep TMS SystemBrainsway, Ltd.20250—
+5K243700Apollo TMS Therapy SystemMag & More GmbH20251—
+5K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251—
+5K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20251—
+5K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited20241—
+6K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH20260—
+6K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—
+6K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj20260—