# K982351: LUNA

- Pathway: 510(k) (Special)
- Applicant: Stellate Systems
- Decided: Jul 29, 1998 after 23 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems’ ECLIPSE Version 3.0 software for MS-DOS®. Luna™ can be used only in conjunction with Stellate Systems’ HARMONIE™ software package. Luna™ may be used for sleep recordings (polysomnography) in research or clinical environments for: • Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers, by means of a personal computer (PC) and PC-based data acquisition board. • Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages. • Manual event-marking and annotation of polygraphic signal sections. • Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals. • Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency, and simple statistical measures of marked events). The software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings. The software requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgment in using this information. The software does not make any judgment of normality or abnormality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.

Source page: https://510kreport.com/device/K982351
Methodology: https://510kreport.com/methodology