ARIA Radiation Therapy Management (v18.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230699 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 System (v18.0) is a software platform designed for comprehensive management of radiation therapy workflows. It integrates treatment planning, delivery, and monitoring to enhance precision and efficiency in radiotherapy for cancer treatment, supporting linear accelerators and associated medical devices.
This system is supplied as a software solution for use in clinical radiation oncology departments, requiring installation on hospital networks or dedicated servers. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance, with no indication of single-use or sterility requirements. The system is compatible with MRI-safe environments where applicable and is authorized for use with multiple linear accelerator models as referenced in its regulatory submissions.
Frequently asked questions
What types of radiation therapy equipment is the ARIA system designed to integrate with?
The ARIA Radiation Therapy Management System (v18.0) is specifically designed to integrate with a wide range of linear accelerators (LINACs) used in radiation therapy. The system supports multiple models of these devices, as referenced by the listed FEI numbers in its regulatory submissions, ensuring compatibility with common equipment in clinical radiation oncology departments.
Is the ARIA system a standalone software solution, or does it require additional hardware?
The ARIA system is supplied as a software platform that requires installation on existing hospital networks or dedicated servers. It does not include physical hardware but relies on integration with existing infrastructure to manage radiation therapy workflows, including treatment planning, delivery, and monitoring.
Does the ARIA system have any specific requirements regarding sterility or single-use?
Since ARIA is a software-based solution for managing radiation therapy workflows, it does not have sterility or single-use requirements. It is designed for repeated use in clinical environments and does not involve disposable or sterile components.
How is the ARIA system authorized for use in the United States?
The ARIA Radiation Therapy Management System (v18.0) has received FDA clearance through a 510(k) submission, classified as a Class II medical device. This authorization confirms its compliance with regulatory standards for use in radiation oncology departments to enhance precision and efficiency in cancer treatment workflows.
Can the ARIA system be used in environments where MRI-compatible equipment is present?
Yes, the ARIA system is designed to be compatible with MRI-safe environments where applicable. This ensures it can be integrated into facilities that utilize both radiation therapy and MRI technologies, supporting comprehensive patient care 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: ARIA Radiation Therapy Management (v18.0) (K230699) — FDA 510(k ..., Aria - Wikipedia, PDF December 13, 2024 Varian Medical Systems, Inc Dr. Lynn Allman Sr ..., ARIA Radiation Therapy Management (v18.0) (K230699) - FDA 510(k), PDF K230699 ARIA Radiation Therapy Management (v18.0)
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 | K230699 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K230699 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 25, 2026