FDA Product Code QCI: Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).
Leading manufacturers include Teleemg, LLC, Neuronetics, Inc. and BTL Industries, Inc..
FDA 510(k) Cleared Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder Devices (Product Code QCI)
About Product Code QCI - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QCI since 2018, with 8 receiving FDA clearance (average review time: 208 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under QCI have taken an average of 160 days to reach a decision - down from 214 days historically, suggesting improved FDA processing for this classification.
QCI devices are reviewed by the Neurology panel. Browse all Neurology devices →