Atomic Energy of Canada: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Atomic Energy of Canada” (first 1977, latest 1985), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 | 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| IWB | System, Radiation Therapy, Radionuclide | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| JAI | Couch, Radiation Therapy, Powered | 1 | 1 |
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 1 | 1 |
Review panels
- Radiology (6)
Most recent Atomic Energy of Canada 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | IWB | 1985-05-10 | 88 |
| K837347 | LINEAR ACCELERATOR THERAC 25 | IYE | 1983-06-24 | 81 |
| K837346 | MODEL GAMMACELL 1000 | MOT | 1983-06-24 | 100 |
| K837152 | THERAC 25 LINEAR ACCELERATOR | JAI | 1983-03-22 | 387 |
| K771260 | LINEAR ACCELERATOR G-2900 | IYE | 1977-08-03 | 21 |
| K771096 | TELHTHERAPY SIMULATOR AECL-CP, G-3200 | JAA | 1977-07-01 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Atomic Energy of Canada.
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.
- Atomic Products Corp. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atomic Energy of Canada?
FDA lists 6 510(k) clearances under the applicant name “Atomic Energy of Canada” (first 1977, latest 1985), 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 Atomic Energy of Canada?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atomic Energy of Canada is 84 days.
Which FDA product codes appear under Atomic Energy of Canada?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 2); IWB (System, Radiation Therapy, Radionuclide, 1); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 6 Atomic Energy of Canada clearances with predicates and recalls
- Run predicate analysis for product code IYE, Atomic Energy of Canada'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.