Dosisoft SA
Country not established
Part of Dosisoft
Dosisoft SA is a medical device manufacturer, with 3 devices listed in FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 3
Registry facts
- Registries
- FDA 510(k) 3
- Device classes
- FDA Class II 3
- Sites and related companies
What Dosisoft SA makes
Dosisoft SA develops software solutions for radiation therapy planning and quality assurance, including treatment planning systems (PLANET series), dose calculation tools (PLANET Dose, PLANET Onco Dose), and real-time monitoring applications (EPIgray). Additional products include artificial intelligence-driven QA tools (ThinkQA, ThinkQA Edition 2) and beam modeling software (EPIbeam), as well as machine learning-based output prediction (MU2net).
The company’s portfolio is regulated under FDA Class II devices, with authorisations recorded via 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system. These products are listed in the US market, where Dosisoft SA is based.
Catalogue
Epigray Ref K112723
Regimes: CE MDD 510(k) Registry: 510(k)PLANET Onco Dose (3.2) Ref K241765
Regimes: CE MDR CE MDD 510(k) Registry: 510(k)Isogray Treatment Planning System Ref K103146
Regimes: CE MDD 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dosisoft SA have in the registry?
The registry currently lists 3 devices for Dosisoft SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dosisoft SA's devices?
Among its 3 most recently registered devices, Dosisoft SA has devices listed in FDA 510(k) (3 devices).
What risk classes do Dosisoft SA's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Dosisoft SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dosisoft SA in the registry?
The most recently registered devices listed for Dosisoft SA include EPIGRAY, PLANET Onco Dose (3.2) and ISOGRAY TREATMENT PLANNING SYSTEM.