ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221448 FDA 510(k)
- FDA Product Code
- IYE 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 ARIA Radiation Therapy Management and Eclipse Treatment Planning System is a Radiation Therapy Management Software and Treatment Planning System designed to integrate and optimize radiation therapy workflows. It combines real-time patient management, treatment planning, and delivery coordination for linear accelerator-based radiation therapy, including photon and proton modalities. The system facilitates precise dose calculations, treatment optimization, and quality assurance to enhance therapeutic outcomes in oncology settings.
This software is supplied as a standalone system for use in radiation oncology departments and is intended for single-use per treatment session with updates via licensed software versions. It operates in non-sterile environments and is compatible with MRI-safe linear accelerators as part of its integrated workflow. Authorized under FDA 510(k) clearance (K221448) and MDR compliance, the system adheres to regulatory standards for radiation therapy management and treatment planning. Version-specific updates (e.g., v15.8) ensure alignment with evolving clinical and regulatory requirements.
Frequently asked questions
What types of radiation therapy modalities does the ARIA Radiation Therapy Management System support for workflow integration?
The ARIA system is designed to integrate and optimize workflows for linear accelerator-based radiation therapy, including both photon and proton modalities. This means it supports both conventional photon therapy (using X-rays) and advanced proton therapy (using proton beams), ensuring comprehensive treatment planning and delivery coordination for these modalities.
Is the ARIA system intended for single-use or repeated use across multiple treatment sessions?
The ARIA Radiation Therapy Management System is intended for single-use per treatment session, with updates provided through licensed software versions. This means each new session or treatment plan typically requires access to the latest version, rather than reusing the same software instance across multiple sessions.
How does the ARIA system ensure compatibility with existing medical equipment in a radiation oncology department?
The ARIA system is explicitly designed to integrate with MRI-safe linear accelerators as part of its workflow. While it does not require sterility (as it operates in non-sterile environments), its compatibility with MRI-safe equipment ensures seamless coordination with advanced imaging and treatment devices already in use within radiation oncology departments.
What regulatory pathways does the ARIA system follow for compliance and clearance?
The ARIA system is authorized under both FDA 510(k) clearance (with the specific clearance number K221448) and MDR (Medical Device Regulation) compliance. This means it has undergone regulatory review to demonstrate substantial equivalence to existing devices and adheres to EU and U.S. standards for radiation therapy management and treatment planning.
How are software updates handled for the ARIA system, and what does this mean for clinical workflows?
Software updates for ARIA are provided through licensed versions (e.g., v15.8), ensuring alignment with evolving clinical and regulatory requirements. This means clinicians must install the latest version to access new features, improvements, or compliance updates, which helps maintain workflow efficiency and adherence to best practices in radiation therapy.
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: ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning ..., Aria - Wikipedia, ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221448 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K221448 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026