Neuromag Vectorview

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K984401 ↗

FDA product code

OLX

Device class

Class II

Regulation

21 CFR Part 882.1400

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

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See all devices from Philips Medical Systems (Cleveland), Inc. →

• What is the Neuromag Vectorview used for?

  The Neuromag Vectorview is used to non-invasively detect and display biomagnetic signals produced by electrically active nerve tissue in the brain, functioning as a source localization software for magnetoencephalograph devices to support neurological assessment.

• How is the Neuromag Vectorview supplied or accessed?

  The Neuromag Vectorview is supplied as a software system integrated with magnetoencephalographic hardware, manufactured by Philips Medical Systems (Cleveland), Inc., and is not a disposable or single-use product but a clinical system intended for repeated use in neurology settings.

• Is the Neuromag Vectorview sterile or single-use?

  The Neuromag Vectorview is not sterile nor single-use; it is a reusable software-based system for detecting brain activity, requiring standard cleaning and maintenance procedures for the associated hardware components as per manufacturer guidelines.

• What regulatory pathway was used for the Neuromag Vectorview?

  The Neuromag Vectorview received FDA 510(k) clearance under submission K984401 on December 30, 1998, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under product code OLX.

• What are the key identifiers for the Neuromag Vectorview in regulatory databases?

  The Neuromag Vectorview is identified by FDA 510(k) number K984401, device name 'Source Localization Software For Electroencephalograph Or Magnetoencephalograph', product code OLX, regulation number 882.1400, and device class II, with FEI numbers including 3014291198 and 3015929663 among others.