Normalizing Quantitative Electroencephalograph Software
FDA product code OLU · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0)OLU · Traditional | VoxNeuro, Inc. | 06/12/2026SE |
| K240420 | NeuroField Analysis SuiteOLU · Traditional | Neurofield, Inc. | 09/20/2024SE |
| K222838 | iSyncBrain©-COLU · Traditional | iMediSync, Inc. | 03/16/2023SE |
| K212684 | BrainView QEEG SoftwareOLU · Traditional | Medeia, Inc. | 01/28/2023SE |
| K202588 | BNA PlatformOLU · Traditional | Elminda, Ltd. | 12/07/2020SE |
| K191432 | cortiQ PROOLU · Traditional | G.Tec Medical Engineering GmbH | 01/24/2020SE |
| K171414 | qEEG-ProOLU · Traditional | Brainmaster Technologies, Inc. | 07/01/2018SE |
| K121119 | Bna Analysis SystemOLU · Traditional | Eiminda , Ltd. | 07/25/2014SE |
| K112077 | Hbidb - Human Brian Index SoftwareOLU · Traditional | Corscience GmbH & Co. KG | 03/09/2012SE |
| K050192 | BRC Software ProductOLU · Traditional | Brc Operations Pty Limited | 10/20/2005SE |
| K041263 | Neuroguide Analysis SystemOLU · Traditional | Applied Neuroscience, Inc. | 08/03/2004SE |
| K974748 | Neurometric Analysis SystemOLU · Traditional | Nxlink, Ltd. | 07/10/1998SE |
| K904294 | Qsi 9500OLU · Traditional | Quantified Signal Imaging, Inc. | 07/30/1991SE |