MRIdian A3i Software
MRIdian A3i Software is a Class II device made by Viewray Incorporated, cleared under FDA 510(k) K212958 on 14 Dec 2021 and listed in FDA GUDID since 5 May 2022 (UDI-DI 00850036816027), 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 | Number00850036816027 | Date5 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212958 | Date14 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 00850036816027
- FDA 510(k) database K212958
Across registries
- FDA 510(k) K212958 decided 14 Dec 2021 Active
- FDA GUDID UDI-DI 00850036816027 listed 5 May 2022 Listed
Timeline
- Cleared FDA 510(k) K212958
- Listed FDA GUDID 00850036816027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Linear accelerator system
- Model / reference
- A3i
- Primary DI / UDI-DI
- 00850036816027
- 510(k) Number
- FDA product code
- IYE, LNH
- GMDN term
- Linear accelerator system
- Device class
- Class II
- Regulation number
- 892.5050, 892.1000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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