Device class
Class II
Regulation 882.1460
Total clearances
7
2020-08-12 → 2026-07-30
Classification details
Medical specialty
Neurology
Regulation number
882.1460
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Neurobit Technologies Co., Ltd. |
1 |
0 |
2023-06-29 |
|
Interacoustics A/S
|
1 |
0 |
2020-08-12 |
|
Natus Medical Denmark Aps |
1 |
0 |
2025-02-14 |
|
Vestibular First |
1 |
0 |
2020-11-12 |
|
Inventis S.R.L. |
1 |
0 |
2025-01-03 |
|
Neuroears, Inc. |
1 |
0 |
2025-08-25 |
|
VertigoDx, Inc. |
1 |
1 |
2026-07-30 |
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 |
| 92534 |
CPT
|
— |
High
|
CPT code for nystagmography testing and evaluation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-30 |
K260566 |
VertigoDx, Inc.
|
SMARTVERTIGO Vestibular Assessment System |
| 2025-08-25 |
K243709 |
Neuroears, Inc.
|
NeuroEars-Anna |
| 2025-02-14 |
K242198 |
Natus Medical Denmark Aps
|
ICS Dizcovery (1091) |
| 2025-01-03 |
K242726 |
Inventis S.R.L.
|
Synapsys VHIT |
| 2023-06-29 |
K223047 |
Neurobit Technologies Co., Ltd.
|
NeuroSwift Pro |
| 2020-11-12 |
K203082 |
Vestibular First
|
Insight Infrared Video Goggles |
| 2020-08-12 |
K200534 |
Interacoustics A/S
|
VisualEyes |