Clearance Summary
MagVenture Accelerated TMS (aTMS) Therapy System received FDA 510(k) clearance under submission number K260189, sponsored by Tonica Elektronik A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-05-22.
- Submission: K260189
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2026-05-22
Classification & Regulation
This clearance is catalogued under FDA product code OBP and 21 CFR 882.5805, within the Neurology review panel as a Class II device.