Viewray, Incorporated: FDA clearances and approvals
Viewray, Incorporated has 6 FDA 510(k) clearances (first 2011, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time: 142 days. Since 2017 its median was 136 days, against 113 days for all cleared 510(k)s in the same product codes. openFDA lists 6 product recalls by a recalling firm named Viewray, Incorporated.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 327 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 134 |
| 2018 | 0 | — |
| 2019 | 1 | 209 |
| 2020 | 0 | — |
| 2021 | 1 | 89 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Viewray, Incorporated's cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (6)
Most recent Viewray, Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212958 | MRIdian Linac System | IYE | 2021-12-14 | 89 |
| K181989 | MRIdian Linac System | IYE | 2019-02-20 | 209 |
| K170751 | MRIdian Linac System with 138-leaf Collimator | IYE | 2017-06-07 | 86 |
| K162393 | The ViewRay (MRIdian) Linac System | IYE | 2017-02-24 | 182 |
| K111862 | VIEWRAY SYSTEM | IYE | 2012-05-22 | 327 |
| K102915 | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM | MUJ | 2011-01-12 | 103 |
Recalls
6 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2016-03-07.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Viewray, Incorporated have?
Viewray, Incorporated has 6 FDA 510(k) clearances (first 2011, latest 2021), across 2 product codes in 1 review panel.
How long does FDA take to clear Viewray, Incorporated's 510(k)s?
The median time from FDA receipt to decision across Viewray, Incorporated's cleared 510(k)s is 142 days. Since 2017: 136 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does Viewray, Incorporated make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 5); MUJ (System, Planning, Radiation Therapy Treatment, 1).
Has Viewray, Incorporated had device recalls?
openFDA lists 6 product recalls in 6 recall events by a recalling firm whose name matches Viewray, Incorporated; the most recent began 2016-03-07. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Viewray, Incorporated clearances with predicates and recalls
- Run predicate analysis for product code IYE, Viewray, Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.