Elekta Oncology Systems, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Elekta Oncology Systems, Ltd.” (first 1997, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
Review panels
- Radiology (5)
Most recent Elekta Oncology Systems, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032996 | ELEKTA SYNERGY SYSTEM | IYE | 2003-10-23 | 28 |
| K012289 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) | IYE | 2001-08-14 | 25 |
| K982713 | RT DESKTOP | IYE | 1998-11-02 | 90 |
| K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW | IYE | 1998-08-07 | 79 |
| K973540 | ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS | IYE | 1997-12-17 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Elekta Oncology Systems, Ltd..
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.
- Elekta Instrument AB (35 510(k)s)
- Elekta Solutions AB (15 510(k)s)
- Elekta , Ltd. (14 510(k)s)
- Elekta Instruments, Inc. (8 510(k)s)
- Elekta Limited (8 510(k)s)
- Elekta Neuromag OY (4 510(k)s)
- Elekta Implants, SA (2 510(k)s)
- Elekta Inc. D/B/A Nucletron Corporation (1 510(k)s)
- Elekta Radiosurgery, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elekta Oncology Systems, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Elekta Oncology Systems, Ltd.” (first 1997, latest 2003), across 1 product code 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 Elekta Oncology Systems, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta Oncology Systems, Ltd. is 79 days.
Which FDA product codes appear under Elekta Oncology Systems, Ltd.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 5 Elekta Oncology Systems, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Elekta Oncology Systems, Ltd.'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.