Automatic Registration
510(k) K234047
Automatic Registration is a Class II device made by Brainlab AG, cleared under FDA 510(k) K234047 on 20 Mar 2024, 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 | NumberK234047 | Date20 Mar 2024 | StatusActive |
Official records
- FDA 510(k) database K234047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K234047
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 | |||
|---|---|---|---|---|
| Automatic Registration 2.6 | 2.6 | 04056481145101 | — | On the market |
| Automatic Regsitration 2.7 | 2.7 | 04056481146429 | — | On the market |
| Calibration Phantom Ict 19148-01A | 19148-01A / 19148-01A | 04056481004569 | — | On the market |
| Drapelink Interface Ict Calib Phantom 19142-06 | 19142-06 / 19142-06 | 04056481004637 | — | On the market |