Dosisoft SA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dosisoft SA” (first 2011, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 232 days. Since 2017 the median was 267 days, against 122 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 142 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 232 |
| 2025 | 1 | 267 |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dosisoft SA took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (5)
Most recent Dosisoft SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252937 | ThinkQA 3 | IYE | 2026-06-12 | 270 |
| K241765 | PLANET Onco Dose (3.2) | LLZ | 2025-03-14 | 267 |
| K231573 | ThinkQA (Edition 2) | IYE | 2024-01-18 | 232 |
| K112723 | EPIGRAY | MUJ | 2012-02-08 | 142 |
| K103146 | ISOGRAY TREATMENT PLANNING SYSTEM | MUJ | 2011-03-11 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Dosisoft SA.
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.
- Dosisoft (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dosisoft SA?
FDA lists 5 510(k) clearances under the applicant name “Dosisoft SA” (first 2011, latest 2026), across 3 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 Dosisoft SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dosisoft SA is 232 days. Since 2017: 267 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dosisoft SA?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 2); MUJ (System, Planning, Radiation Therapy Treatment, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Dosisoft SA clearances with predicates and recalls
- Run predicate analysis for product code IYE, Dosisoft SA'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.