# K141883: Cliniscansm Eeg

- Pathway: 510(k) (Traditional)
- Applicant: Picofemto, LLC
- Decided: May 15, 2015 after 308 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- 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: 1 generation back to K001781 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011397: Persyst Reveal, Persyst Development Corp. (2001) Summary page 4.
- K001781: Curry Multimodal Neuroimaging Software, Neurosoft, Inc. (2001) Summary page 4.

## Indications for use
1. CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data. 2. The Seizure Detection component of CliniscanSM EEG is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. 3. CliniscanSM EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system. 4. The user may annotate the data, and the annotations are stored with the EEG recording in the cloud. 5. CliniscanSM EEG displays standard qEEG features to the user including FFT Power Spectrum, Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Localization Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma). 6. CliniscanSM EEG detects seizure events for review by qualified medical professionals. 7. CliniscanSM EEG is designed to provide analytics data derived from a patient’s input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.

Source page: https://510kreport.com/device/K141883
Methodology: https://510kreport.com/methodology