EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

The EEG-1260A Neurofax is an electroencephalograph system for recording, measuring, and displaying brain electrical activity (EEG) and sleep study signals in medical facilities. The JE-940A EEG Amplifier Unit acquires EEG and polysomnography signals (ECG, EMG, respiration, EOG, SpO2, etc.) and transmits data to the main unit. The LS-940A Photic Stimulator provides flashing light stimuli to test EEG responsiveness and visual evoked potentials.

The EEG-1260A has identical technological characteristics to its predicate (EEG-1200A). The JE-940A has identical technological characteristics to its predicate (JE-921A). The LS-940A has identical technological characteristics to its predicate (Lifelines Photic Stimulator). Design differences include updated cybersecurity (AES-256 encryption, FIPS 140-2 compliance), new software features (burst-suppression identification, seizure detection), enhanced amplifier capabilities (24-bit A/D conversion, higher input impedance), and battery operation support.

Testing conducted per ISO 14971:2019 (risk management), IEC 62304:2006+A1:2015 (software life cycle), IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 80601-2-26:2019 (EEG equipment), ISO 80601-2-61:2017 (pulse oximetry), IEC 62366-1:2015+A1:2020 (usability), ISO 10993-1:2018 (biocompatibility), and IEC 62471:2006 (photobiological safety).

The three devices are substantially equivalent because they maintain the same indications for use, intended use, and regulatory classification as their respective predicates. Design and performance improvements comply with current applicable standards without impacting safety or effectiveness. All devices have been evaluated using the same test methods and specifications as their predicates, and non-clinical testing demonstrates equivalency across electrical safety, electromagnetic compatibility, software validation, and usability.