MRIdian LINAC 20000
MRIdian LINAC 20000 is a Class II device made by Viewray Incorporated, cleared under FDA 510(k) K162393 on 24 Feb 2017 and listed in FDA GUDID since 20 Mar 2017 (UDI-DI 10868029000305), 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 | Number10868029000305 | Date20 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162393 | Date24 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 10868029000305
- FDA 510(k) database K162393
Across registries
- FDA 510(k) K162393 decided 24 Feb 2017 Active
- FDA GUDID UDI-DI 10868029000305 listed 20 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K162393
- Listed FDA GUDID 10868029000305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MRIdian LINAC
- Generic name
- Linear accelerator system
- Model / reference
- 20000
- Primary DI / UDI-DI
- 10868029000305
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Linear accelerator system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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