Monaco
by Elekta Solutions AB 2 variants
Monaco is a Class II device made by Elekta Solutions AB, cleared under FDA 510(k) K213787 on 17 May 2022 and listed in FDA GUDID since 11 Jul 2022 (UDI-DI 07340201500033), active as of 21 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 | Number07340201500033 | Date11 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213787 | Date17 May 2022 | StatusActive |
Official records
- AccessGUDID record 07340201500033
- FDA 510(k) database K213787
Across registries
- FDA 510(k) K213787 decided 17 May 2022 Active
- FDA GUDID UDI-DI 07340201500033 listed 11 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K213787
- Listed FDA GUDID 07340201500033
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy software
- Model / reference
- Monaco
- Primary DI / UDI-DI
- 07340201500033
- 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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