Decimal3D
Decimal3D is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K192554 on 13 Dec 2019 and listed in FDA GUDID since 1 Dec 2022 (UDI-DI 00851147007113), 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 | Number00851147007113 | Date1 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192554 | Date13 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 00851147007113
- FDA 510(k) database K192554
Across registries
- FDA 510(k) K192554 decided 13 Dec 2019 Active
- FDA GUDID UDI-DI 00851147007113 listed 1 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K192554
- Listed FDA GUDID 00851147007113
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy software
- Primary DI / UDI-DI
- 00851147007113
- 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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