OLU
13 FDA 510(k) clearances · Product code
240 daysmedian time to decision
522 days90th percentile
13clearances measured
FDA profile
- Official device name
- Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- FDA definition
- Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
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| Record | Firm | Date |
|---|---|---|
| Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (K253015) | VoxNeuro, Inc. | 2026-06-12 |
| NeuroField Analysis Suite (K240420) | Neurofield, Inc. | 2024-09-20 |
| iSyncBrain©-C (K222838) | iMediSync, Inc. | 2023-03-16 |
| BrainView QEEG Software (K212684) | Medeia, Inc. | 2023-01-28 |
| BNA Platform (K202588) | Elminda, Ltd. | 2020-12-07 |
| cortiQ PRO (K191432) | G.Tec Medical Engineering GmbH | 2020-01-24 |
| qEEG-Pro (K171414) | Brainmaster Technologies, Inc. | 2018-07-01 |
| BNA ANALYSIS SYSTEM (K121119) | Eiminda , Ltd. | 2014-07-25 |
| HBIDB - HUMAN BRIAN INDEX SOFTWARE (K112077) | Corscience GmbH & Co. KG | 2012-03-09 |
| BRC SOFTWARE PRODUCT (K050192) | Brc Operations Pty Limited | 2005-10-20 |
| NEUROGUIDE ANALYSIS SYSTEM (K041263) | Applied Neuroscience, Inc. | 2004-08-03 |
| NEUROMETRIC ANALYSIS SYSTEM (K974748) | Nxlink, Ltd. | 1998-07-10 |
| QSI 9500 (K904294) | Quantified Signal Imaging, Inc. | 1991-07-30 |
Track OLU automatically
Every clearance here is in the API, with alerts when new ones post.