Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k) K253098 · Nexstim Oyj
510(k) numberK253098
Submission
- Device name
- Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- Applicant
- Nexstim Oyj
Helsinki, FI - Received
- September 23, 2025
- Decision date
- March 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBP – Transcranial Magnetic Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Specialty
- Neurology
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Other 510(k)s with product code OBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional | Fidelity BioPharma Co. | 09/06/2026SE |
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional | Mag & More GmbH | 05/22/2026SE |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | Tonica Elektronik A/S | 05/22/2026SE |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K251653 | SPRY TMS Therapy System (0550)OBP · Traditional | Soterix Medical, Inc. | 02/20/2026SE |
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 11/07/2025SE |
| K250689 | CloudTMS EdgeOBP · Traditional | Teleemg, LLC | 09/14/2025SE |
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 09/13/2025SE |
More from Brainsway , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | 03/20/2026SE |
Questions and answers
When was Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) cleared by the FDA?
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K253098) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 178 days after the submission was received.
What is the product code of K253098?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.