Class Class II
MagVenture TMS Therapy System (K251119)
Description
MagVenture TMS Therapy System by Tonica Elektronik A/S, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251119
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeOBP
Regulation Number882.5805
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251119
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. MagVenture TMS Therapy System (K251119) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 |
| K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 |
| K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260691 | BTL-699 | BTL Industries, Inc. | 2026 |
Trace the full predicate network for K251119
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.