# K190703: Neuro-IOM system with Neuro-IOM.NET software

- Pathway: 510(k) (Traditional)
- Applicant: Neurosoft, Ltd.
- Decided: May 22, 2021 after 796 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: 1 generation back to K093304 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093304: Protektor 32, Natus Medical, Inc. (2010) Summary page 4.

## Most influential descendants
- K234080: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (2024), 0 descendants of its own

## Indications for use
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: 1.32/B II. 32/8 III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.

Source page: https://510kreport.com/device/K190703
Methodology: https://510kreport.com/methodology