VIEWRAY SYSTEM
FDA 510(k) clearance K111862 · decided 2012-05-22
Clearance details
- K-number
- K111862
- Device name
- VIEWRAY SYSTEM
- Applicant
- Viewray, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2011-06-30
- Decision date
- 2012-05-22
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Oakwood Village, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MRIdian Linac Radiation Therapy System Model 10000 and 20000 recall (Z-0676-2020) | Viewray, Inc. | 2019-12-12 |
| MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System ( recall (Z-1309-2016) | Viewray Incorporated | 2016-03-31 |
| MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. recall (Z-0806-2016) | Viewray Incorporated | 2016-02-12 |
| MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurge recall (Z-0115-2016) | Viewray Incorporated | 2015-10-09 |
| Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotact recall (Z-2085-2015) | Viewray Incorporated | 2015-07-16 |
| Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereo recall (Z-1954-2015) | Viewray Incorporated | 2015-07-02 |
| ViewRay System, Radiation Therapy System recall (Z-1580-2015) | Viewray Incorporated | 2015-05-05 |