510(k) Report

Devices descending from K230029

13 later devices reach NeuroStar Advanced Therapy System (Version 3.7) through their predicates, nearest generation first.

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