Cleared Traditional

MagView BIOMAGNETOMETER SYSTEM

K152184 · Tristan Technologies, Inc. · Neurology

Apr 2016

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K152184 is an FDA 510(k) clearance for the MagView BIOMAGNETOMETER SYSTEM, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Tristan Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on April 8, 2016, 247 days after receiving the submission on August 5, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K152184 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2015
Decision Date	April 08, 2016
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLY — Magnetoencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Biomagnetic Signals Produced By Electrically Active Nerve Tissue In The Brain To Provide Information About The Location Of Active Nerve Tissue Responsible For Certain Brain Functions Relative To Brain Anatomy.