Sun Nuclear Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0959-2015 | Class II | IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for m | August 8, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170307 | SunCHECK | October 25, 2017 |
| K161946 | DoseCHECK | September 16, 2016 |
| K160057 | ArcCHECK-MR | May 13, 2016 |
| K142617 | ArcCHECK | November 20, 2015 |
| K150848 | Dose Calculator | May 20, 2015 |
| K142431 | WaterProof PROFILER | December 5, 2014 |
| K142142 | QUALITY REPORTS | December 5, 2014 |
| K141800 | PERFRACTION | September 26, 2014 |
| K131862 | 3DVH | August 21, 2013 |
| K131466 | MAPCHECK2, ARCCHECK | August 20, 2013 |
| K131704 | EPIDOSE | August 5, 2013 |