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ARIA Radiation Therapy Management 18.1

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref ARIA Radiation Therapy Management 18.1510(k) K173838

by Varian Medical Systems, Inc.

Identity

Trade Name
ARIA Radiation Therapy Management EUDAMEDFDA UDI
Generic Name
Radiation therapy software FDA UDI
Device Name
ARIA Radiation Therapy Management EUDAMED
Model / Reference
ARIA Radiation Therapy Management 18.1 EUDAMED
18.1 FDA UDI

Identifiers

Primary DI / UDI-DI
00856100006370 EUDAMEDFDA UDI
Basic UDI-DI
089947500200119PV EUDAMED
510(k) Number
K242463 FDA UDI
FDA Product Code
MUJ FDA UDI
EMDN Code
Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Radiation therapy software FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The ARIA Radiation Therapy Management is a Radiation Oncology Treatment Management System (Nomenclature Code: Z11010492), designed to integrate and manage radiation therapy workflows. It provides real-time data acquisition, treatment planning, and delivery verification for external beam radiotherapy, ensuring precise dose delivery and patient safety through advanced software and hardware integration.

This system is supplied as a non-sterile, non-reusable software-based solution, intended for use in radiation oncology departments within hospitals or specialized clinics. It operates as an active medical device (Class IIb, FDA 510(k) clearance, and MDR compliance) and does not require sterilization or reprocessing. The system supports MRI-safe environments and is available in a single version (18.1) with a unique UDI (089947500200119PV). Storage and handling follow manufacturer guidelines for electronic medical devices.

Frequently asked questions

What is the ARIA Radiation Therapy Management system primarily used for in a clinical setting?

The ARIA Radiation Therapy Management system is designed to integrate and manage radiation therapy workflows for external beam radiotherapy. It provides real-time data acquisition, treatment planning, and delivery verification to ensure precise dose delivery and enhance patient safety by streamlining the entire radiation oncology process in hospitals or specialized clinics.

Is the ARIA system reusable or does it require sterilization?

The ARIA Radiation Therapy Management is a non-reusable, non-sterile software-based solution. Since it is an electronic medical device, it does not require sterilization or reprocessing, and it is intended for single-use within its designated environment.

What version of ARIA is currently available, and how is it identified?

The latest version of ARIA available is 18.1, and it is uniquely identified by its UDI (089947500200119PV). This version is the only one currently marketed and does not require additional updates or upgrades beyond the manufacturer’s guidelines.

Can the ARIA system be used in environments with MRI equipment, and how should it be stored?

Yes, the ARIA Radiation Therapy Management system is designed to operate in MRI-safe environments. Storage and handling should follow the manufacturer’s guidelines for electronic medical devices, which typically include protection from physical damage, extreme temperatures, and electrostatic discharge.

How is the regulatory status of ARIA determined, and which committees were involved?

The ARIA system holds FDA 510(k) clearance and MDR compliance, classified as a Class IIb active medical device. It was reviewed by the Radiology (RA) Advisory Committee and received a 'Substantially Equivalent' decision under a special clearance type, with the submission filed under product code IYE.

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 - Wikipedia

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Varian Medical Systems, Inc.
EUDAMED SRN
US-MF-000001784
Authorised Representative
Siemens Healthineers Nederland B.V. NL-AR-000000803

Sources (3)

  • EUDAMED 2fcd25ff-9895-4df7-9ef5-1ed3c6450495 85 fields · synced Oct 6, 2026
  • FDA UDI 34f0fea1-c5f2-4376-8cb9-e32094dc67c8 33 fields · synced May 30, 2026
  • FDA 510(k) K173838 1 fields · synced May 18, 2026