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Planet Onco Dose 3.2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241765

by Dosisoft SA

Identifiers

510(k) Number
K241765 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Planet Onco Dose 3.2 is a radiology dosimetry software platform designed to calculate and analyze radiation dose distributions in medical imaging and radiotherapy. It provides tools for assessing dose metrics, optimizing treatment plans, and ensuring compliance with radiation safety standards in clinical workflows.

The device is supplied as a software solution for use in radiology departments, hospitals, or oncology centers. It operates on standard computing hardware and is intended for single-use per session, though the software license may allow repeated use across multiple cases. Authorized under FDA 510(k) clearance (K241765) and compliant with EU MDR (Class IIb), it does not require sterile packaging or specialized MRI safety considerations.

Frequently asked questions

What clinical workflows is the Planet Onco Dose 3.2 software designed to support specifically within radiology and oncology settings?

The Planet Onco Dose 3.2 software is designed to support radiation dose calculations and analysis in both medical imaging and radiotherapy workflows. It helps clinicians assess dose metrics, optimize treatment plans for radiotherapy, and ensure compliance with radiation safety standards—key functions for radiology departments, hospitals, and oncology centers.

How is the Planet Onco Dose 3.2 software supplied, and does it require any specialized hardware or sterile packaging?

The software is supplied as a standalone digital solution for standard computing hardware, meaning no specialized equipment is required beyond a compatible computer. Since it is a software platform, it does not require sterile packaging or physical sterilization, as it is intended for single-use per session (though the license allows repeated use across multiple cases).

Is the Planet Onco Dose 3.2 software reusable across different patient cases, or is it intended for one-time use?

The software itself is licensed for repeated use across multiple patient cases, but it is designed for single-use per session. This means you can install it on a single machine and utilize it for various cases, but each session’s data and calculations are independent. The license model allows flexibility for clinical workflows without requiring reinstallation.

What regulatory pathways has the Planet Onco Dose 3.2 software undergone, and what does that mean for its use in clinical settings?

The software has been cleared under the FDA’s 510(k) pathway (K241765) and is compliant with the EU Medical Device Regulation (MDR) as a Class IIb device. This means it has undergone review for safety and performance by regulatory bodies, ensuring it meets established standards for radiation dose calculation and analysis in clinical environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Planet dose a dosimetry solution - DOSIsoft, Dosisoft Planet Onco Dose (3.2) - allmed.wiki, PLANET Onco Dose (3.2) (K241765) - FDA 510(k), PLANET Onco Dose (3.2) | FDA Radiology AI Device

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dosisoft SA

Sources (2)

  • FDA 510(k) K241765 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026