Viewray, Inc.
Mountain View, CA, US
Viewray, Inc. appears in FDA device records in Mountain View, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 6
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1836-2021 | 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 radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system. | Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. | Class II | Terminated | |
| Z-0482-2021 | 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 Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user. | Class II | Terminated | |
| Z-0481-2021 | 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 Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user. | Class II | Terminated | |
| Z-1803-2020 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software | Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed. | Class II | Terminated | |
| Z-1251-2019 | MRIdian Linac Radiation Therapy System, Model 20000. | A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. | Class II | Terminated | |
| Z-0676-2020 | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain