DeviceClearance

Product code OLX— Neurology

700 SERIES BIOMAGNETOMETER

Classification name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
25
First cleared
Most recent

FDA classification definition

“Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization”

— U.S. Food and Drug Administration, device classification record for product code OLX under 21 CFR 882.1400, via openFDA

Market context for product code OLX

FDA has cleared 25 devices under product code OLX between 1990 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OLX

Recent clearances under product code OLX

Data sourced from openFDA. This site is unofficial and independent of the FDA.