.decimal Proton Range Compensator 2.8
.decimal Proton Range Compensator 2.8 is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K071078 on 22 May 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851147007014), active as of 22 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 | Number00851147007014 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071078 | Date22 May 2007 | StatusActive |
Official records
- AccessGUDID record 00851147007014
- FDA 510(k) database K071078
Across registries
- FDA 510(k) K071078 decided 22 May 2007 Active
- FDA GUDID UDI-DI 00851147007014 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K071078
- Listed FDA GUDID 00851147007014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- .decimal Proton Range Compensator
- Generic name
- Radiation therapy beam block material
- Model / reference
- 2.8
- Primary DI / UDI-DI
- 00851147007014
- 510(k) Number
- FDA product code
- IXI
- GMDN term
- Radiation therapy beam block material
- Device class
- Class II
- Regulation number
- 892.5710
- GUDID distribution status
- In Commercial Distribution
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