510(k) K181989 ยท IYE Accelerator, Linear, Medical
MRIdian Linac System
| Applicant | Viewray, Incorporated, Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 20, 2019 |
| Received | Jul 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2021 | Viewray, Inc. ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurge Terminated |
MUJ | None listed |
| Oct 20, 2020 | Viewray, Inc. ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI.
The MRIdian system and the MRIdian Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.