Nicolet EDX

The Nicolet EDX is a computer-based electrodiagnostic system for acquiring, displaying, analyzing, and reporting electrophysiological information from the nervous and muscular systems. It performs nerve conduction studies (NCS), electromyography (EMG), evoked potentials (EP), autonomic response testing, and intra-operative neuromonitoring including EEG, and is intended for use by qualified healthcare providers in professional clinical settings.

The Nicolet EDX maintains identical specifications to its primary predicate (K120979) across all major parameters: 1-8 channel isolated amplifier, 24-bit A/D conversion at 384 kHz sampling, 1-2 electrical stimulators with constant current or voltage capability, auditory stimulators, LED goggle visual stimulation, and Windows-based software interface with Natus Elite. It supports the same application modules for NCS, EMG, evoked potentials, and autonomic testing, with integrated ultrasound display capability matching the reference predicate (K243495).

Not stated in this summary.

The Nicolet EDX demonstrates substantial equivalence because its indications for use are identical to the primary predicate, all technological characteristics remain unchanged (same channel count, signal acquisition specifications, stimulator capabilities, and software platform), and it maintains the same intended use environment and target population. The device performs the identical set of diagnostic modalities and functions through the same hardware architecture and software approach as the predicates, with no modifications that would alter safety or effectiveness.