# K111055: Galaxy System; Jupiter

- Pathway: 510(k) (Traditional)
- Applicant: Personal Health Institute International
- Decided: Dec 21, 2011 after 250 days
- Product code: OLV (Standard Polysomnograph With 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: 4 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 6.
- K100683: Neurolink IP Model: PK1117, Natus Medical Incorporated (2010) Summary page 1.

## Indications for use
The Galaxy System (which includes the Jupiter amplifier and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

Source page: https://510kreport.com/device/K111055
Methodology: https://510kreport.com/methodology