# K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Nov 1, 2006 after 142 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: 5 generations back to K842956 (1984). 23 ancestors in all.
426 later devices descend from it; 2 cite it directly.
1 of 450 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050798: Eclipse Neurological Workstation, Axon Systems, Inc. (2005) Summary page 2.
- K051739: Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB., Multigon Industries, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), 246 descendants of its own

## Indications for use
The systems are intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status. Doppler analysis is not to be used for Obstetrics.

Source page: https://510kreport.com/device/K061639
Methodology: https://510kreport.com/methodology