# K234080: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

- Pathway: 510(k) (Traditional)
- Applicant: Soterix Medical, Inc.
- Decided: Mar 25, 2024 after 94 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: 2 generations back to K093304 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190703: Neuro-IOM system with Neuro-IOM.NET software, Neurosoft, Ltd. (2021) Summary page 5.

## Indications for use
MEGA-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 three different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potential), MEP (motor evoked potential), EEG (electroencephalography), AEP (auditory evoked potential), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure vital signs. It records the data to be interpreted by the neuromonitoring specialist. MEGA-IOM system is intended for use in adults age 18 years and older.

Source page: https://510kreport.com/device/K234080
Methodology: https://510kreport.com/methodology