K212958 is an FDA 510(k) clearance for the MRIdian Linac System. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Viewray, Incorporated (Mountain View, US). The FDA issued a Cleared decision on December 14, 2021, 89 days after receiving the submission on September 16, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K212958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2021 |
| Decision Date | December 14, 2021 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |