Nucletron Corp.: FDA clearances and approvals
Nucletron Corp. has 49 FDA 510(k) clearances (first 1995, latest 2011), across 6 product codes in 1 review panel. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 26 | 26 |
| MUJ | System, Planning, Radiation Therapy Treatment | 12 | 12 |
| KPQ | System, Simulation, Radiation Therapy | 5 | 5 |
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (49)
Most recent Nucletron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113102 | ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING | MUJ | 2011-12-12 | 54 |
| K112420 | ONCENTRA PROSTATE 4.0 | JAQ | 2011-11-18 | 87 |
| K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET | JAQ | 2011-09-21 | 71 |
| K103515 | EQUAL DOSE | MUJ | 2011-09-15 | 289 |
| K092804 | MICROSELECTRON HDR V2, MODEL 105.999 | JAQ | 2009-10-08 | 27 |
| K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS | JAQ | 2009-06-29 | 26 |
| K090706 | ONCENTRA SIMULATION 2.3 | KPQ | 2009-06-15 | 90 |
| K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, | JAQ | 2009-05-18 | 27 |
| K082642 | ONCENTRA RT VIEWER 1.0 | MUJ | 2008-11-07 | 57 |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | JAQ | 2008-05-28 | 56 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nucletron Corp..
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 Nucletron Corp. have?
Nucletron Corp. has 49 FDA 510(k) clearances (first 1995, latest 2011), across 6 product codes in 1 review panel.
How long does FDA take to clear Nucletron Corp.'s 510(k)s?
The median time from FDA receipt to decision across Nucletron Corp.'s cleared 510(k)s is 70 days.
What devices does Nucletron Corp. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 26); MUJ (System, Planning, Radiation Therapy Treatment, 12); KPQ (System, Simulation, Radiation Therapy, 5).
Has Nucletron Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Nucletron Corp. Related entities may recall under other names.
Next steps
- See all 49 Nucletron Corp. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Nucletron Corp.'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.