Elekta Instrument AB: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Elekta Instrument AB” (first 1996, latest 2019), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 112 days, against 121 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 | 1 | 69 |
| 2013 | 0 | — |
| 2014 | 1 | 170 |
| 2015 | 3 | 76 |
| 2016 | 2 | 119 |
| 2017 | 1 | 151 |
| 2018 | 2 | 82 |
| 2019 | 1 | 119 |
| 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 Instrument AB took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 16 | 16 |
| IWB | System, Radiation Therapy, Radionuclide | 13 | 13 |
| MUJ | System, Planning, Radiation Therapy Treatment | 4 | 4 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
Review panels
Most recent Elekta Instrument AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190887 | Leksell Vantage Stereotactic System | HAW | 2019-08-01 | 119 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | IWB | 2018-03-30 | 106 |
| K173791 | Leksell GammaPlan | IWB | 2018-02-09 | 57 |
| K171123 | Leksell Vantage Stereotactic System | HAW | 2017-09-15 | 151 |
| K160440 | Leksell Gamma Knife Icon | IWB | 2016-04-20 | 63 |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | HAW | 2016-03-02 | 175 |
| K151159 | Leksell Gamma Knife Perfexion | IWB | 2015-10-29 | 181 |
| K151666 | Leksell GammaPlan | MUJ | 2015-09-03 | 76 |
| K151561 | Leksell Gamma Knife Icon | IWB | 2015-08-04 | 55 |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | IWB | 2014-05-09 | 170 |
25 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 3 initiated in the last five years. Most recent: 2024-09-25.
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 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 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 Instrument AB?
FDA lists 35 510(k) clearances under the applicant name “Elekta Instrument AB” (first 1996, latest 2019), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Elekta Instrument AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta Instrument AB is 88 days. Since 2017: 112 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elekta Instrument AB?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 16); IWB (System, Radiation Therapy, Radionuclide, 13); MUJ (System, Planning, Radiation Therapy Treatment, 4).
Next steps
- See all 35 Elekta Instrument AB clearances with predicates and recalls
- Run predicate analysis for product code HAW, Elekta Instrument AB'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.