Sun Nuclear Corp.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Sun Nuclear Corp.” (first 1988, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 111 |
| 2013 | 3 | 58 |
| 2014 | 3 | 98 |
| 2015 | 2 | 240 |
| 2016 | 2 | 92 |
| 2017 | 1 | 266 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sun Nuclear Corp. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 19 | 19 |
| KPT | Calibrator, Dose, Radionuclide | 2 | 2 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (24)
Most recent Sun Nuclear Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170307 | SunCHECK | IYE | 2017-10-25 | 266 |
| K161946 | DoseCHECK | IYE | 2016-09-16 | 63 |
| K160057 | ArcCHECK-MR | IYE | 2016-05-13 | 122 |
| K142617 | ArcCHECK | IYE | 2015-11-20 | 430 |
| K150848 | Dose Calculator | IYE | 2015-05-20 | 50 |
| K142431 | WaterProof PROFILER | IYE | 2014-12-05 | 98 |
| K142142 | QUALITY REPORTS | IYE | 2014-12-05 | 122 |
| K141800 | PERFRACTION | IYE | 2014-09-26 | 85 |
| K131862 | 3DVH | IYE | 2013-08-21 | 58 |
| K131466 | MAPCHECK2, ARCCHECK | IYE | 2013-08-20 | 91 |
14 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sun Nuclear Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Sun Nuclear Corp. (13)
- Sun Nuclear Corporation (11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sun Nuclear Corp.?
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Sun Nuclear Corp.” (first 1988, latest 2017), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sun Nuclear Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sun Nuclear Corp. is 76 days.
Which FDA product codes appear under Sun Nuclear Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 19); KPT (Calibrator, Dose, Radionuclide, 2); KXK (Source, Brachytherapy, Radionuclide, 1).
Next steps
- See all 24 Sun Nuclear Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Sun Nuclear Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.