Device class
Class II
Regulation 882.1400
Total clearances
7
2020-12-22 → 2026-08-16
Definition
What is Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
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 |
|
Clouds of Care |
1 |
1 |
2026-02-13 |
|
Megin OY |
1 |
0 |
2024-05-15 |
|
FIND Surgical Sciences Inc. D/B/A FIND Neuro |
1 |
1 |
2026-08-16 |
|
LVIS Corporation
|
1 |
0 |
2025-05-23 |
|
Brain Electrophysiology Laboratory Company, LLC |
1 |
0 |
2024-09-27 |
|
Neurologic, LLC |
1 |
0 |
2020-12-22 |
|
Ricoh Company, Ltd. |
1 |
0 |
2021-07-02 |
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 neuroimaging correlation and source localization |
| 95819 |
CPT
|
— |
Medium
|
Electroencephalogram; source localization software typically billed with comprehensive EEG analysis |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-16 |
K260563 |
FIND Surgical Sciences Inc. D/B/A FIND Neuro
|
CN-Suite |
| 2026-02-13 |
K252565 |
Clouds of Care
|
PreOp v3 |
| 2025-05-23 |
K250239 |
LVIS Corporation
|
NeuroMatch |
| 2024-09-27 |
K241513 |
Brain Electrophysiology Laboratory Company, LLC
|
Sourcerer |
| 2024-05-15 |
K233985 |
Megin OY
|
TRIUX neo (NM27000N ); MEGreview (SW26241N-B) |
| 2021-07-02 |
K210199 |
Ricoh Company, Ltd.
|
RICOH MEG |
| 2020-12-22 |
K201910 |
Neurologic, LLC
|
EZTrack |