Cleared Traditional

Orion LifeSpan MEG

K191785 · Compumedics Limited · Neurology

Feb 2020

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K191785 is an FDA 510(k) clearance for the Orion LifeSpan MEG, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on February 14, 2020, 226 days after receiving the submission on July 3, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K191785 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2019
Decision Date	February 14, 2020
Days to Decision	226 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.