Nucletron-Oldelft Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Nucletron-Oldelft Corp.” (first 1986, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 189 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Elekta, based on public ownership records.
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 | 7 | 7 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
Review panels
- Radiology (11)
Most recent Nucletron-Oldelft Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953946 | MICROSELECTRON-HDR VERSION 2 | JAQ | 1996-08-13 | 358 |
| K953831 | N 800 HF | IZO | 1995-09-08 | 24 |
| K925956 | MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT | JAQ | 1993-11-19 | 360 |
| K926407 | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | KXJ | 1993-03-31 | 100 |
| K921991 | PLATO RADIATION THERAPY PLANNING SYSTEM | IYE | 1992-11-27 | 213 |
| K915622 | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM | JAQ | 1992-09-25 | 284 |
| K911612 | NUCLETRON PLANNING SYSTEM | IYE | 1991-06-13 | 63 |
| K902533 | PULSED SELECTRON | JAQ | 1990-10-12 | 126 |
| K864210 | MICROSELECTRON-HDR (HIGH DOSE RATE) | JAQ | 1986-11-26 | 29 |
| K853912 | MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS | JAQ | 1986-05-21 | 243 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nucletron-Oldelft Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nucletron Corp. (49 510(k)s)
- Nucletron B.V. (12 510(k)s)
- Nucletron Mfg. Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nucletron-Oldelft Corp.?
FDA lists 11 510(k) clearances under the applicant name “Nucletron-Oldelft Corp.” (first 1986, latest 1996), across 4 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 Nucletron-Oldelft Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nucletron-Oldelft Corp. is 189 days.
Which FDA product codes appear under Nucletron-Oldelft Corp.?
The most frequent FDA product codes under this applicant name are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 7); IYE (Accelerator, Linear, Medical, 2); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 1).
Next steps
- See all 11 Nucletron-Oldelft Corp. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Nucletron-Oldelft 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.