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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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