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510(k) K171902

Nexstim Navigated Brain Therapy (NBT) System 2 by Nexstim Plc — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2017
Date Received
June 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

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 clearances by Nexstim Plc

  • K182700 — Nexstim Navigated Brain Therapy (NBT) System 2 (March 22, 2019)
  • K112881 — NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NE (May 22, 2012)
  • K091457 — NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM (December 8, 2009)

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  • K251449 — BrainsWay Deep TMS System (September 13, 2025)
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  • K251125 — MagVenture TMS Therapy System (August 11, 2025)
  • K251119 — MagVenture TMS Therapy System (August 8, 2025)
  • K252032 — T65 (9016E061-) (July 30, 2025)
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