Cleared Traditional

HORIZON TMS Therapy System with Navigation

K183376 · Magstim Company, Ltd. · Neurology

Apr 2019

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K183376 is an FDA 510(k) clearance for the HORIZON TMS Therapy System with Navigation, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Magstim Company, Ltd. (Whitland, GB). The FDA issued a Cleared decision on April 3, 2019, 118 days after receiving the submission on December 6, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K183376 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2018
Decision Date	April 03, 2019
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OBP — Transcranial Magnetic Stimulator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5805
Definition	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.