Isogray Treatment Planning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Dosisoft SA
Identifiers
- 510(k) Number
- K103146 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Isogray Treatment Planning System is a radiation therapy treatment planning device designed for calculating and optimizing radiation dose distributions in cancer treatment. It supports advanced planning techniques, including inverse planning and aperture-based planning, to enhance precision in delivering therapeutic radiation doses to targeted tissues while minimizing exposure to healthy areas.
This system is supplied as software for use in radiation oncology departments, typically integrated into existing treatment planning workflows. It is intended for single-use in clinical settings and does not require sterilisation. The device operates within Class II regulatory classification under FDA and MDD frameworks, with FDA 510(k) clearance and MDD authorisation. No specific MRI safety or reusable component details are provided in the specifications.
Frequently asked questions
What is the Isogray Treatment Planning System used for in clinical practice?
The Isogray Treatment Planning System is designed specifically for calculating and optimizing radiation dose distributions in cancer treatment. It supports advanced techniques like inverse planning and aperture-based planning to improve precision when delivering therapeutic radiation doses to tumors while sparing surrounding healthy tissue.
How is the Isogray Treatment Planning System supplied and does it require sterilization?
The Isogray Treatment Planning System is supplied as software for use in radiation oncology departments. Since it is a software-based solution, it does not require sterilization and is intended for single-use in clinical settings, integrated into existing workflows.
Is the Isogray Treatment Planning System reusable or single-use, and what does that mean for its use?
The Isogray Treatment Planning System is intended for single-use in clinical settings, meaning each installation or deployment is typically for one specific treatment planning session or workflow. This does not refer to physical reuse but rather the software’s role in a single planning process before potentially being updated or reinstalled for another case.
What regulatory pathways has the Isogray Treatment Planning System undergone, and which committees were involved?
The Isogray Treatment Planning System has received FDA 510(k) clearance and MDD authorization, placing it under Class II regulatory classification. The FDA submission was reviewed by the Radiology (RA) Advisory Committee, with the decision classified as substantially equivalent (SESE) under the traditional clearance type.
Does the Isogray Treatment Planning System have any specific storage requirements or limitations?
As a software-based system, the Isogray Treatment Planning System does not have physical storage requirements like traditional medical devices. However, it must be installed on compatible hardware within radiation oncology departments, adhering to IT security and data protection protocols to ensure proper functionality and compliance with clinical workflows.
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: Radiation therapy software - ISOgray® - DOSIsoft - treatment planning, home - DOSIsoft, ISOGRAY TREATMENT PLANNING SYSTEM by DOSISOFT SA | FDA 510(k) Summary
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K103146 | Class II | Active |
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Manufacturer
- Manufacturer
- Dosisoft SA
Sources (2)
- FDA 510(k) K103146 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026