Elekta Limited: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Elekta Limited” (first 2011, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 102 days, against 106 days for all cleared 510(k)s in the same product codes. 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 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 1 | 58 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 125 |
| 2019 | 2 | 90 |
| 2020 | 0 | — |
| 2021 | 1 | 109 |
| 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 Elekta Limited took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 7 | 7 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (8)
Most recent Elekta Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | IYE | 2021-06-11 | 109 |
| K192482 | Elekta Unity | IYE | 2019-12-05 | 86 |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | IYE | 2019-11-22 | 95 |
| K182076 | Elekta Unity | IYE | 2018-12-04 | 125 |
| K153011 | iViewDose R1.0 | IYE | 2015-12-11 | 58 |
| K131965 | XVI R5.0 | IYE | 2013-09-25 | 90 |
| K112613 | INTEGRITY(TM) | IYE | 2011-12-16 | 100 |
| K111676 | APEX | IXI | 2011-09-30 | 107 |
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2020-05-21.
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 Oncology Systems, Ltd. (5 510(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 Limited?
FDA lists 8 510(k) clearances under the applicant name “Elekta Limited” (first 2011, latest 2021), across 2 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 Elekta Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta Limited is 98 days. Since 2017: 102 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elekta Limited?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 7); IXI (Block, Beam-Shaping, Radiation Therapy, 1).
Next steps
- See all 8 Elekta Limited clearances with predicates and recalls
- Run predicate analysis for product code IYE, Elekta Limited'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.