# K083577: Harmonie System

- Pathway: 510(k) (Abbreviated)
- Applicant: Stellate Systems
- Decided: Aug 29, 2011 after 999 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003154 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010728: Harmone-Schwarzer Eeg System, Stellate Systems (2001)
- K053606: BE Plus / Aura-LTM64 Amplifier, Eb Neuro S.P.A. (2006) Summary page 1.

## Recalls of this device
- Apr 6, 2009 · Class II · Z-1080-2013: The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.

## Indications for use
The Harmonie System is indicated for the acquisition, display, review, analysis and archiving of physiological signals including patient video obtained during routine EEG examinations, Long-Term Monitoring in Epilepsy (LTM) and Sleep Studies (polysomnography or PSG) in patients of all ages. The seizure detection component of the software is intended for post-hoc review for marking sections of the EEG that may correspond to electrographic seizures in adults only. The Burst-Suppression component is intended to be used for the quantification and recognition (mark) of sections of the EEG and PSG that may contain patterns of interest. The seizure detection component and Burst-Suppression Module are for use in adults only. The Harmonie software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings. In no way are any of the system functions represented as being in and of themselves diagnostic. The system requires competent user input, and its Output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K083577
Methodology: https://510kreport.com/methodology