K183303 is an FDA 510(k) clearance for the Brainsway Deep TMS System. This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II - Special Controls, product code QCI).
Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on March 8, 2019, 101 days after receiving the submission on November 27, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5802. 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)..
| 510(k) Number | K183303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2018 |
| Decision Date | March 08, 2019 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QCI - Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5802 |
| Definition | 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). |