Brainomix 360 Hyperdensity
510(k) K260406
Brainomix 360 Hyperdensity is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K260406 on 12 Jun 2026, 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 | NumberK260406 | Date12 Jun 2026 | StatusActive |
Official records
- FDA 510(k) database K260406
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K260406
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 | |||
|---|---|---|---|---|
| Brainomix 360 Hyperdensity 14.4 | 14.4 | B720BX360HYPERDENSI1440 | — | On the market |
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