BCIwiki (bciwiki.com) — Nihon Kohden's EEG-1260A Neurofax system, along with its JE-940A EEG Amplifier Unit and LS-940A Photic Stimulator, received FDA 510(k) clearance on October 9, 2025. The FDA decision, recorded as "substantially equivalent," was a traditional 510(k) clearance for a Class II device under the Neurology advisory committee, with regulation number 882.1400.
The device is classified under the name "Non-Normalizing Quantitative Electroencephalograph Software," indicating that its software functions include quantitative EEG analysis. The 510(k) clearance is a premarket notification pathway for moderate-risk devices, signifying that the device is substantially equivalent to a legally marketed predicate.