510(k) K253015
- Device
- Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
- Applicant
- VoxNeuro, Inc.
- 510(k) number
- K253015
- Product code
- OLU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2025-09-19
- Regulation
- 882.1400
- Classification name
- Normalizing Quantitative Electroencephalograph Software
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Andrew Matiasso
- Address
- 121 King St. W Suite 2150 Toronto CA M5H 3T9 M5H 3T9
FDA Registration Numbers#
- 3038189172
- 3008008477
- 3016851752
- 3023707151
- 3007048291
- 3010900508
- 3008660657
- 3004577596
- 3010376446
- 1531052
- 3010536822
- 3005713796
Source Documents#
Other 510(k) Records For Product Code OLU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | 2024-09-20 |
| K222838 | iSyncBrain©-C | iMediSync, Inc. | 2023-03-16 |
| K212684 | BrainView QEEG Software | Medeia, Inc. | 2023-01-28 |
| K202588 | BNA Platform | Elminda, Ltd. | 2020-12-07 |
| K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | 2020-01-24 |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018-07-01 |
| K121119 | BNA ANALYSIS SYSTEM | Eiminda , Ltd. | 2014-07-25 |
| K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | Corscience GmbH & Co. KG | 2012-03-09 |
| K050192 | BRC SOFTWARE PRODUCT | Brc Operations Pty Limited | 2005-10-20 |
| K041263 | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | 2004-08-03 |
| K974748 | NEUROMETRIC ANALYSIS SYSTEM | Nxlink, Ltd. | 1998-07-10 |
| K904294 | QSI 9500 | Quantified Signal Imaging, Inc. | 1991-07-30 |