Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ViewRay with 12 device recalls and 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 14, 2021: MRIdian Linac System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 14, 2021 | MRIdian Linac SystemK212958 · IYE | 510(k) clearances |
| May 4, 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiatClass II · Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. | Device recalls |
| Oct 20, 2020 | ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in AmpClass II · There is a potential that components of the receive coil can reach elevated temperatures which has the potential to caus | Device recalls |
| Oct 20, 2020 | ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input Class II · There is a potential that components of the receive coil can reach elevated temperatures which has the potential to caus | Device recalls |
| Nov 18, 2019 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) soClass II · Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the | Device recalls |
| Mar 18, 2019 | MRIdian Linac Radiation Therapy System, Model 20000.Class II · A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose cal | Device recalls |
| Mar 3, 2019 | MRIdian Linac Radiation Therapy System Model 10000 and 20000Class II · Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment | Device recalls |
| Feb 20, 2019 | MRIdian Linac SystemK181989 · IYE | 510(k) clearances |
| Jun 7, 2017 | MRIdian Linac System with 138-leaf CollimatorK170751 · IYE | 510(k) clearances |
| Feb 24, 2017 | The ViewRay (MRIdian) Linac SystemK162393 · IYE | 510(k) clearances |
| May 22, 2012 | VIEWRAY SYSTEMK111862 · IYE | 510(k) clearances |
| Jan 12, 2011 | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEMK102915 · MUJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
