Class Class II
Ultimate rTMS for OCD (M-series) (K243459)
Description
Ultimate rTMS for OCD (M-series) by Brain Ultimate, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243459
Clearance Date2025-04-17
Clearance TypeTraditional
Product CodeQCI
Regulation Number882.5802
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243459
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ultimate rTMS for OCD (M-series) (K243459) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture T... | Tonica Elektronik A/S | 2020 |
Trace the full predicate network for K243459
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.