NMI Software

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K950270 ↗

FDA Product Code

OMB

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Nicolet Vasoguard

  Class II

  FDA 510(k) K002766 Active Cleared 30 Nov 2000

• Brainet

  Class II

  FDA 510(k) K021986 Active Cleared 23 Aug 2002

• Nicolet Electromagnetic Navigation System

  Class II

  FDA 510(k) K013419 Active Cleared 20 Dec 2001

• Nicolet Pioneer TC8080

  Class II

  FDA 510(k) K020754 Active Cleared 21 Apr 2003

• Caredop II

  Class II

  FDA 510(k) K982635 Active Cleared 7 Aug 1998

• Nicolet Electrocautery Detector

  Class II

  FDA 510(k) K020955 Active Cleared 17 Apr 2002

See all devices from Nicolet Biomedical, Inc. →

• What is the NMI Software designed to do within an EEG system?

  The NMI Software is an Automatic Event Detection Software integrated into full-montage electroencephalograph (EEG) systems. It processes EEG recordings to identify and flag epileptiform events—abnormal brain wave patterns—helping neurologists detect and analyze these events more efficiently. This assists in diagnosing neurological conditions by streamlining the interpretation of EEG data.

• Who is this software intended for, and where is it used?

  The NMI Software is intended for use in clinical settings by trained professionals, specifically neurologists or EEG technicians. It is designed to support diagnostic workflows by enhancing the detection of epileptiform activity during EEG monitoring. The software is part of an integrated EEG system and is not standalone.

• Is the NMI Software single-use or reusable, and what about sterility?

  The available data does not specify whether the NMI Software is single-use or reusable. Since it is a software component of an EEG system, its usability depends on the system’s hardware and maintenance protocols. There is no mention of sterility requirements, as software itself is not subject to sterility standards like physical medical devices.

• What regulatory pathway does the NMI Software follow?

  The NMI Software is classified as a Class II medical device under FDA regulations (21 CFR 882.1400) and has received FDA 510(k) clearance (K950270). This clearance confirms it is substantially equivalent to a predicate device, meaning it meets the same performance standards as an existing approved product. The software is regulated under the OMB product code and reviewed by the Neurology Advisory Committee.

• Can this software be used with any EEG system, or is it specific to Nicolet’s hardware?

  The NMI Software is supplied as part of an integrated EEG system developed by Nicolet Biomedical, Inc. While the data does not explicitly state compatibility with non-Nicolet systems, its design suggests it is tailored for use within Nicolet’s EEG platforms. Clinicians should verify system compatibility with their specific hardware before implementation.