System 2100
System 2100 is a Class II device made by Math Resolutions, LLC, cleared under FDA 510(k) K993530 on 15 Dec 1999 and listed in FDA GUDID since 17 Jun 2016 (UDI-DI B229S210011), active as of 8 Jun 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 | NumberB229S210011 | Date17 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993530 | Date15 Dec 1999 | StatusActive |
Official records
- FDA 510(k) database K993530
Across registries
- FDA 510(k) K993530 decided 15 Dec 1999 Active
- FDA GUDID UDI-DI B229S210011 listed 17 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K993530
- Listed FDA GUDID B229S210011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy software
- Model / reference
- 1
- Primary DI / UDI-DI
- B229S210011
- 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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