NeuralScan System
by Medeia, Inc.
510(k) K192753
NeuralScan System is a Class II device made by Medeia, Inc., cleared under FDA 510(k) K192753 on 17 Mar 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192753 | Date17 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K192753
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWQ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192753
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BrainView NeuralScan HW9N | HW9N | 08690020003062 | — | On the market |
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