FDA 510(k) Applications for Medical Device Product Code "QCI"

FDA 510(k) Number Applicant Device Name Decision Date
K183303 Brainsway Ltd. Brainsway Deep TMS System 03/08/2019
DEN170078 Brainways Ltd. Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System 08/17/2018
K231350 Neuronetics OCD MT Cap (85-00397-000) 06/08/2023
K212289 Neuronetics, Inc NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar 05/06/2022
K221129 TeleEMG, LLC CloudTMS for OCD 03/10/2023
K193006 Tonica Elektronik A/S MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system 08/09/2020


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