EPIgray 2.0.7
by Dosisoft
EPIgray 2.0.7 is a Class II device made by Dosisoft, cleared under FDA 510(k) K112723 on 8 Feb 2012 and listed in FDA GUDID since 7 Aug 2019 (UDI-DI B501EPIGRAY020007), active as of 12 Nov 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 | NumberB501EPIGRAY020007 | Date7 Aug 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112723 | Date8 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K112723
Across registries
- FDA 510(k) K112723 decided 8 Feb 2012 Active
- FDA GUDID UDI-DI B501EPIGRAY020007 listed 7 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K112723
- Listed FDA GUDID B501EPIGRAY020007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EPIgray
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- 2.0.7
- Primary DI / UDI-DI
- B501EPIGRAY020007
- 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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