Elekta Solutions AB: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Elekta Solutions AB” (first 2020, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 129 days. Since 2017 the median was 129 days, against 125 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 |
|---|---|---|
| 2020 | 1 | 53 |
| 2021 | 3 | 101 |
| 2022 | 2 | 134 |
| 2023 | 3 | 128 |
| 2024 | 1 | 146 |
| 2025 | 2 | 150 |
| 2026 | 3 | 185 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Elekta Solutions AB took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| MUJ | System, Planning, Radiation Therapy Treatment | 4 | 4 |
| IWB | System, Radiation Therapy, Radionuclide | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 1 | 1 |
Review panels
Most recent Elekta Solutions AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | HAW | 2026-08-05 | 57 |
| K252002 | Monaco RTP System (6.3) | MUJ | 2026-02-19 | 237 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | IYE | 2026-01-15 | 185 |
| K251363 | ProKnow DS | LLZ | 2025-10-08 | 160 |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | IWB | 2025-07-02 | 140 |
| K232854 | Leksell GammaPlan (LGP) | IWB | 2024-02-08 | 146 |
| K223233 | Monaco RTP System | MUJ | 2023-02-23 | 127 |
| K223229 | MOSAIQ® OIS (Oncology Information System) | IYE | 2023-02-23 | 128 |
| K223209 | Elekta Unity | IYE | 2023-02-23 | 129 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | IWB | 2022-10-26 | 106 |
5 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2025-09-17.
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 , 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 Solutions AB?
FDA lists 15 510(k) clearances under the applicant name “Elekta Solutions AB” (first 2020, latest 2026), across 6 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 Solutions AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta Solutions AB is 129 days. Since 2017: 129 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elekta Solutions AB?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 5); MUJ (System, Planning, Radiation Therapy Treatment, 4); IWB (System, Radiation Therapy, Radionuclide, 3).
Next steps
- See all 15 Elekta Solutions AB clearances with predicates and recalls
- Run predicate analysis for product code IYE, Elekta Solutions 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.