Elekta , Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Elekta , Ltd.” (first 2005, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 33 days, against 113 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 | 3 | 183 |
| 2013 | 1 | 114 |
| 2014 | 1 | 91 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 33 |
| 2019 | 1 | 56 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 , Ltd. took a median 33 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 12 | 12 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
Review panels
- Radiology (14)
Most recent Elekta , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190178 | Monaco RTP System | MUJ | 2019-03-29 | 56 |
| K183037 | Monaco RTP System | MUJ | 2018-12-04 | 33 |
| K183034 | MOSAIQ Oncology Information System | IYE | 2018-12-04 | 33 |
| K141855 | CLARITY | IYE | 2014-10-08 | 91 |
| K123808 | AGILITY | IYE | 2013-04-04 | 114 |
| K121663 | CLARITY | IYE | 2012-12-05 | 183 |
| K121328 | AGILITY | IYE | 2012-06-12 | 40 |
| K111332 | CLARITY OBP SYSTEM | IYE | 2012-01-30 | 264 |
| K102200 | INTEGRITY MODEL 1014284 | IYE | 2010-11-04 | 92 |
| K100115 | XVI R4.5 | IYE | 2010-03-10 | 54 |
4 earlier clearances. See the full list in Caduvo.
Recalls
156 product recalls in 145 recall events; 23 initiated in the last five years. Most recent: 2026-05-21.
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 Instruments, Inc. (8 510(k)s)
- Elekta Limited (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 , Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Elekta , Ltd.” (first 2005, latest 2019), 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 , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta , Ltd. is 74 days. Since 2017: 33 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elekta , Ltd.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 12); MUJ (System, Planning, Radiation Therapy Treatment, 2).
Next steps
- See all 14 Elekta , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Elekta , 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.