Device class
Class II
Regulation 882.1400
Total clearances
6
2020-01-24 → 2026-06-12
Definition
What is Normalizing Quantitative Electroencephalograph Software
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Classification details
Medical specialty
Neurology
Regulation number
882.1400
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Elminda, Ltd. |
1 |
0 |
2020-12-07 |
|
Neurofield, Inc.
|
1 |
0 |
2024-09-20 |
|
VoxNeuro, Inc. |
1 |
1 |
2026-06-12 |
|
iMediSync, Inc. |
1 |
0 |
2023-03-16 |
|
G.Tec Medical Engineering GmbH |
1 |
0 |
2020-01-24 |
|
Medeia, Inc.
|
1 |
0 |
2023-01-28 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 95957 |
CPT
|
— |
High
|
Digital analysis and interpretation of electroencephalogram with normative database comparison and quantitative output |
| 95819 |
CPT
|
— |
Medium
|
Electroencephalogram initial service; normalizing qEEG analysis typically billed with base EEG code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-12 |
K253015 |
VoxNeuro, Inc.
|
Cognitive Function Neuroimaging (cfNI) Software (1.0.0) |
| 2024-09-20 |
K240420 |
Neurofield, Inc.
|
NeuroField Analysis Suite |
| 2023-03-16 |
K222838 |
iMediSync, Inc.
|
iSyncBrain©-C |
| 2023-01-28 |
K212684 |
Medeia, Inc.
|
BrainView QEEG Software |
| 2020-12-07 |
K202588 |
Elminda, Ltd.
|
BNA Platform |
| 2020-01-24 |
K191432 |
G.Tec Medical Engineering GmbH
|
cortiQ PRO |