Alignment Software Cranial with LITT 2.1
by Brainlab SE
Alignment Software Cranial with LITT 2.1 is a Class II device made by Brainlab SE, cleared under FDA 510(k) K243698 on 28 Jan 2025 and listed in FDA GUDID since 24 Feb 2025 (UDI-DI 04056481146337), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04056481146337 | Date24 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243698 | Date28 Jan 2025 | StatusActive |
Official records
- AccessGUDID record 04056481146337
- FDA 510(k) database K243698
Across registries
- FDA 510(k) K243698 decided 28 Jan 2025 Active
- FDA GUDID UDI-DI 04056481146337 listed 24 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K243698
- Listed FDA GUDID 04056481146337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alignment Software Cranial with LITT
- Generic name
- Electromagnetic/optical surgical navigation/tracking system
- Model / reference
- 2.1
- Primary DI / UDI-DI
- 04056481146337
- 510(k) Number
- FDA product code
- HAW
- GMDN term
- Electromagnetic/optical surgical navigation/tracking system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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