MillComp 1
MillComp 1 is a Class II device made by Math Resolutions, LLC, cleared under FDA 510(k) K011845 on 4 Dec 2001 and listed in FDA GUDID since 17 Jun 2016 (UDI-DI B229MC11), 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 | NumberB229MC11 | Date17 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011845 | Date4 Dec 2001 | StatusActive |
Official records
- FDA 510(k) database K011845
Across registries
- FDA 510(k) K011845 decided 4 Dec 2001 Active
- FDA GUDID UDI-DI B229MC11 listed 17 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K011845
- Listed FDA GUDID B229MC11
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MillComp
- Generic name
- Radiation therapy software
- Model / reference
- 1
- Primary DI / UDI-DI
- B229MC11
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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