Data / Medical devices / France / Dosisoft
Dosisoft: FDA-registered device maker in Cachan Ile-de-France, France, 7 510(k) clearances
Dosisoft is registered with the FDA (registration 3009302839) in Cachan Ile-de-France, France. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009302839
- Address
- 45/47 Avenue Carnot, Cachan Ile-de-France, France, 94230
- Owner or operator
- DOSISOFT (10035847)
- Roles
- Manufacturer
- First device listed
- March 23, 2012
- Registered through
- 2026
- Brand names listed
- EPIbeam, Epigray, MU2net, PLANET, PLANET Dose, PLANET Onco, PLANET Onco Dose, PLANET Onco Dose (3.2) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K252937 | ThinkQA 3 | IYE | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
| March 14, 2025 | K241765 | PLANET Onco Dose (3.2) | LLZ | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
| January 18, 2024 | K231573 | ThinkQA (Edition 2) | IYE | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
| October 24, 2019 | K191944 | MU2net | IYE | Substantially Equivalent | Dosisoft | accessdata.fda.gov |
| March 6, 2019 | K182966 | PLANET Onco Dose | LLZ | Substantially Equivalent | Dosisoft | accessdata.fda.gov |
| March 13, 2018 | K180106 | ThinkQA | IYE | Substantially Equivalent | Dosisoft | accessdata.fda.gov |
| February 8, 2012 | K112723 | EPIGRAY | MUJ | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Accelerator, Linear, Medical
- All makers of System, Planning, Radiation Therapy Treatment
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.