Limbus Contour 1.6.0
Limbus Contour 1.6.0 is a Class II device made by Limbus Ai Inc., cleared under FDA 510(k) K201232 on 13 Aug 2020 and listed in FDA GUDID since 9 May 2022 (UDI-DI 00628011382160), 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 | Number00628011382160 | Date9 May 2022 | StatusListed |
| United States | FDA 510(k) | NumberK201232 | Date13 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 00628011382160
- FDA 510(k) database K201232
Across registries
- FDA 510(k) K201232 decided 13 Aug 2020 Active
- FDA GUDID UDI-DI 00628011382160 listed 9 May 2022 Listed
Timeline
- Cleared FDA 510(k) K201232
- Listed FDA GUDID 00628011382160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Limbus Contour
- Generic name
- Radiation therapy software
- Model / reference
- 1.6.0
- Primary DI / UDI-DI
- 00628011382160
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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