NeuroAlign software
510(k) K231897
NeuroAlign software is a medical device (FDA Class II; FDA product code HAW, Neurological Stereotaxic Instrument) made by Medivis, Inc., cleared under FDA 510(k) K231897 on 21 Oct 2025, 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 | NumberK231897 | Date21 Oct 2025 | StatusActive |
Official records
- FDA 510(k) database K231897
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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