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ARIA Radiation Therapy Management 15.6

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref ARIA Radiation Therapy Management 15.6

by Varian Medical Systems, Inc.

Identity

Trade Name
ARIA Radiation Therapy Management 15.6 EUDAMED
ARIA Radiation Therapy Management Software FDA UDI
Generic Name
Radiation therapy treatment record/verify system FDA UDI
Device Name
ARIA Radiation Therapy Management EUDAMED
Model / Reference
ARIA Radiation Therapy Management 15.6 EUDAMED
15.6 FDA UDI

Identifiers

Primary DI / UDI-DI
00856100006110 EUDAMEDFDA UDI
Basic UDI-DI
B-00856100006110 EUDAMED
510(k) Number
K173838 FDA UDI
FDA Product Code
IYE FDA UDI
EMDN Code
Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMED
GMDN Term
Radiation therapy treatment record/verify system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Special Device Type
-1192 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

ARIA Radiation Therapy Management 15.6 by Varian Medical Systems, Inc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
US-MF-000001784
Authorised Representative
Siemens Healthineers Nederland B.V. NL-AR-000000803

Sources (2)

  • EUDAMED 682f8fde-76d2-4c02-8b07-706fa1297593 61 fields · synced Jul 9, 2026
  • FDA UDI b1f981f2-79df-4574-80e5-6e4b9a975b6d 33 fields · synced May 30, 2026