# K050798: Eclipse Neurological Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Aug 15, 2005 after 139 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 K842956 (1984). 12 ancestors in all.
460 later devices descend from it; 3 cite it directly.
1 of 473 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation, Axon Systems, Inc. (2003) Summary page 1.
- K020400: Digitimer D185 Multipulse Cortical Stimulator, Meps, LLC (2002) Summary page 1.
- K032083: Nuvasive Neurovision JJB System, Nuvasive, Inc. (2003) Summary page 1.
- K021807: Grass-Telefactor AS40 Amplifier System, Grass Instrument Co. (2002) Summary page 1.

## Most influential descendants
- K061113: Orthomon (2006), 450 descendants of its own
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon (2006), 426 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K123270: Powerease System (2013), 398 descendants of its own

## Indications for use
The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.

Source page: https://510kreport.com/device/K050798
Methodology: https://510kreport.com/methodology