Clinical Trial Records – NeuroStar Advanced Therapy System (K212289, predicate K193006)

510(K) Number: K212289
Device Name: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
Manufacturer: Neuronetics, Inc
Device Classification Name: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation Number: 882.5802
Classification Product Code: QCI
Date Received: 07/21/2021
Decision Date: 05/06/2022
Regulation Medical Specialty: Neurology
Request Contents: Clinical trial records filed with the FDA in support of the NeuroStar Advanced Therapy System (adjunctive treatment of OCD), approved on 5/6/2022 as K212289. Primary predicate device is MagVenture TMS Therapy System K193006, which may also have clinical trial records.