Data / Medical devices / United States / Viewray Systems, Inc.
Viewray Systems, Inc.: FDA-registered device maker in Oakwood Village, OH, United States, 1 510(k) clearance
Viewray Systems, Inc. is registered with the FDA (registration 3007546534) in Oakwood Village, OH, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 14, 2021. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007546534
- Address
- 2 Thermo Fisher Way, Oakwood Village, OH, United States, 44146
- Owner or operator
- Viewray Systems, Inc. (10090487)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 3, 2024
- Registered through
- 2026
- Brand names listed
- MRIdian A3i System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 14, 2021 | K212958 | MRIdian Linac System | IYE | Substantially Equivalent | Viewray, Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 7, 2016 | 73550 | Class II | Terminated | 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 lesions, tumors, and c | When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location. | accessdata.fda.gov |
| December 24, 2015 | 73086 | Class II | Terminated | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | The system loaded a completion fraction in the incorrect order after a treatment interruption. | accessdata.fda.gov |
| August 27, 2015 | 72166 | Class II | Terminated | 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 treatment is indicated. | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. | accessdata.fda.gov |
| May 7, 2015 | 71505 | Class II | Terminated | 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 radiation treatment i | The software was failing to determine new patient locations if imaging is not enabled during treatment. | accessdata.fda.gov |
| April 1, 2015 | 71555 | Class II | Terminated | 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 radiation treatment is in | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. | accessdata.fda.gov |
| January 15, 2015 | 71050 | Class II | Terminated | ViewRay System, Radiation Therapy System | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.