Objective brain data, ready for the clinic.
The UB ERP System is an FDA 510(k)-cleared, EEG-based medical device that records the brain's electrical activity and measures event-related potentials — a data-driven aid to diagnosis.
UB ERP System
Objective brain data, built for the clinic. The UB ERP System is an EEG-based medical device that records, stores and reports the brain's electrical activity and measures event-related potentials (ERPs)* — giving qualified clinicians a data-driven aid to diagnosis in adult and adolescent patients. A modular cap with dry EEG electrodes enables a simple setup, so a clinical-grade recording takes minutes, and does not require a specialist lab.
FDA 510(k) cleared · K253767 · Class II (21 CFR 882.1400) · Rx Only · Refer to the Instructions for Use for the full Indication for Use.
- Oddball · Single Deviantactive — standard & target
- Oddball · Single Deviantpassive — standard & target
- Oddball · 2 Deviantactive novel — + novel
- Flankerscompatible & incompatible
- Doorsgain & loss outcomes
Measured peak amplitude & latency derived from raw EEG (P300 criterion: peak 300–600 ms, >5 μV). Representative example — not real patient data.
Specifications and ERP task paradigms above reflect the technological characteristics and cleared task set described in the 510(k) summary (K253767). Provided for reference — refer to the Indication for Use for the authorized intended use.
* Only P300 ERP measurement has been cleared by the FDA. Other ERP measures — RewP / FRN, LPP and N2 / ERN — are for investigational use only and have not been cleared by the US FDA.
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