510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984401Substantially Equivalent

Neuromag Vectorview

Philips North America LLC, Cleveland OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K984401 is the FDA 510(k) clearance record for NEUROMAG VECTORVIEW, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph). FDA's definition for product code OLX reads: "Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization". FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K984401.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Philips Medical Systems (Cleveland), Inc. 595 Miner Rd., Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code OLX

Trailing 12 months
2 clearances under product code OLX in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260