# K192572: CNS Envision

- Pathway: 510(k) (Traditional)
- Applicant: Moberg Research, Inc.
- Decided: Dec 17, 2019 after 90 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K875179 (1988). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080217: Component Neuromonitoring System, Moberg Research, Inc. (2008) Summary page 5.
- K182181: Persyst 14 EEG Review and Analysis Software, Persyst Development Corporation (2018) Summary page 5.

## Indications for use
CNS Envision is intended for use by qualified personnel in the review, annotation, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score. CNS Envision includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveforms. These include, for example, frequency bands, asymmetry, and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The aEEG functionality included in CNS Envision is intended to monitor the state of the brain. CNS Envision is intended for use by a physician or other qualified medical personnel who will exercise professional judgement in using the information. It is intended for use on patients of all ages. This device does not provide any diagnostic conclusion about the patient’s condition to the user.

Source page: https://510kreport.com/device/K192572
Methodology: https://510kreport.com/methodology