510(k) K111862 ยท IYE Accelerator, Linear, Medical
VIEWRAY SYSTEM
| Applicant | Viewray, Incorporated, Oakwood Village OH, US |
| Decision | Substantially Equivalent, May 22, 2012 |
| Received | Jun 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2020 | Viewray, Inc. ViewRay MRIdian System: Model No. 10000, 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 Lin 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 31, 2016 | Viewray Incorporated MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for le Terminated |
IYE | None listed |
| Feb 12, 2016 | Viewray Incorporated MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. Terminated |
IYE | None listed |
| Oct 9, 2015 | Viewray Incorporated MRIdian ViewRay Radiation Therapy System, ViewRay
Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatm Terminated |
IYE | None listed |
| Jul 16, 2015 | Viewray Incorporated Patient Handling System (Motion Control Software),
Product Usage:
Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when rad Terminated |
IYE | None listed |
| Jul 2, 2015 | Viewray Incorporated Treatment Planning and Delivery System Software version 3.6. ViewRay.
Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when Terminated |
IYE | None listed |
| May 5, 2015 | Viewray Incorporated ViewRay System, Radiation Therapy System Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.