OLY — Magnetoencephalograph Class II

FDA Device Classification

Classification Details

Product Code
OLY
Device Class
Class II
Regulation Number
882.1400
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191785compumedics limitedOrion LifeSpan MEGFebruary 14, 2020
K152184tristan technologiesMagView BIOMAGNETOMETER SYSTEMApril 8, 2016
K133419tristan technologiesBABYMEG BIOMAGNETOMETER SYSTEMJuly 21, 2014
K962317biomagnetic technologiesMAGNES 2500 WH BIOMAGNETOMETERMay 7, 1997
K962764philips medical systems (cleveland)NEUROMAG-122October 31, 1996
K854466biomagnetic technologiesBIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETERFebruary 4, 1986