Monaco 6.2
Monaco 6.2 is a Class II device made by Elekta Solutions AB, cleared under FDA 510(k) K223233 on 23 Feb 2023 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 07340201500064), 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 | Number07340201500064 | Date4 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223233 | Date23 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 07340201500064
- FDA 510(k) database K223233
Across registries
- FDA 510(k) K223233 decided 23 Feb 2023 Active
- FDA GUDID UDI-DI 07340201500064 listed 4 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K223233
- Listed FDA GUDID 07340201500064
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Monaco
- Generic name
- Radiation therapy software
- Model / reference
- 6.2
- Primary DI / UDI-DI
- 07340201500064
- 510(k) Number
- FDA product code
- MUJ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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