NeuroField Analysis Suite
FDA 510(k) clearance K240420 · decided 2024-09-20
Clearance details
- K-number
- K240420
- Device name
- NeuroField Analysis Suite
- Applicant
- Neurofield, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-13
- Decision date
- 2024-09-20
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- OLU
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bishop, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (K253015) | VoxNeuro, Inc. | 2026-06-12 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.