OLU — Normalizing Quantitative Electroencephalograph Software Class II
FDA product code OLU covers "Normalizing Quantitative Electroencephalograph Software", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLU
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253015 | voxneuro | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | June 12, 2026 |
| K240420 | neurofield | NeuroField Analysis Suite | September 20, 2024 |
| K222838 | imedisync | iSyncBrain©-C | March 16, 2023 |
| K212684 | medeia | BrainView QEEG Software | January 28, 2023 |
| K202588 | elminda | BNA Platform | December 7, 2020 |
| K191432 | g.tec medical engineering | cortiQ PRO | January 24, 2020 |
| K171414 | brainmaster technologies | qEEG-Pro | July 1, 2018 |
| K121119 | eiminda | BNA ANALYSIS SYSTEM | July 25, 2014 |
| K112077 | corscience gmbh and co. kg | HBIDB - HUMAN BRIAN INDEX SOFTWARE | March 9, 2012 |
| K050192 | brc operations pty limited | BRC SOFTWARE PRODUCT | October 20, 2005 |
| K041263 | applied neuroscience | NEUROGUIDE ANALYSIS SYSTEM | August 3, 2004 |
| K974748 | nxlink | NEUROMETRIC ANALYSIS SYSTEM | July 10, 1998 |
| K904294 | quantified signal imaging | QSI 9500 | July 30, 1991 |