Topographic Brain Mapping Option

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934050 ↗

FDA Product Code

OLT

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 Biosound, Inc. →

• What is the Topographic Brain Mapping Option used for?

  The Topographic Brain Mapping Option is a non-normalizing quantitative electroencephalograph software designed for brain mapping applications in neurology-related diagnostic procedures. It helps clinicians visualize and analyze brain activity patterns.

• How is the Topographic Brain Mapping Option supplied and what models are available?

  The device is supplied by Biosound, Inc. and is available in multiple sizes and configurations as indicated by various model numbers and registration numbers associated with this clearance. This allows for flexibility in different clinical settings.

• What is the regulatory status of the Topographic Brain Mapping Option?

  The device has FDA 510(k) clearance with K number K934050, granted on February 3, 1994. It is classified as a Class II medical device under product code OLT and regulated under number 882.1400.

• Can the Topographic Brain Mapping Option be reused or is it single-use?

  The device is software-based rather than a physical instrument, so reuse is not applicable in the traditional sense. It can be used multiple times as long as it's installed on compatible hardware and maintained according to manufacturer guidelines.