TraumaCad Neo
by Brainlab Ltd
510(k) K231498
TraumaCad Neo is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab Ltd, cleared under FDA 510(k) K231498 on 20 Nov 2023, 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 | NumberK231498 | Date20 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K231498
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Brainlab , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231498
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 | |||
|---|---|---|---|---|
| TraumaCad Neo 1.0 | 1.0 | 07290109943008 | — | On the market |
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