K-number	K242446
Device name	Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Applicant	Persyst Development Corporation
Product code	OMB
Device class	Class II
Decision date	Jan 22, 2025
Decision	Substantially Equivalent
Regulation	882.1400

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Persyst 15 is EEG review and analysis software that helps neurologists assess electroencephalogram recordings. It provides automated detection of seizures and spikes, sleep state classification, quantitative EEG measurements, artifact reduction, and imaging workflow capabilities for both adult and pediatric patients.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Everything you need for a 510(k) submission. Nothing you don't.