510(k) K170751 ยท IYE Accelerator, Linear, Medical
MRIdian Linac System with 138-leaf Collimator
| Applicant | Viewray, Incorporated, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Mar 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170751
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 12, 2019 | Viewray, Inc. MRIdian Linac Radiation Therapy System Model 10000 and 20000 Terminated |
IYE | None listed |
| Nov 18, 2019 | Viewray, Inc. ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software Terminated |
IYE | None listed |
| Mar 18, 2019 | Viewray, Inc. MRIdian Linac Radiation Therapy System, Model 20000. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.