K243459
- 510(k) number
- K243459
- Device name
- Ultimate rTMS for OCD (M-series)
- Applicant
- Brain Ultimate, Inc. GA · US
- Product code
- QCI — Transcranial Magnetic Stimulation System For Obsessi
- Decision date
- 2025-04-17
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243459.pdf
Official FDA record: K243459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.