Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARIA Radiation Therapy Management (v18.0)

K-Number: K230699 · 2023-04-10

ApplicantVarian Medical Systems, Inc.
Decision Date2023-04-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARIA Radiation Therapy Management (v18.0) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-04-10 under approval number K230699. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIA Radiation Therapy Management (v18.0)?

ARIA Radiation Therapy Management (v18.0) is a medical device that received FDA 510(k) clearance on 2023-04-10. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K230699.

When was ARIA Radiation Therapy Management (v18.0) approved by the FDA?

ARIA Radiation Therapy Management (v18.0) received FDA 510(k) clearance on 2023-04-10, under approval number K230699.

What company makes ARIA Radiation Therapy Management (v18.0)?

ARIA Radiation Therapy Management (v18.0) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for ARIA Radiation Therapy Management (v18.0)?

The FDA product code for ARIA Radiation Therapy Management (v18.0) is IYE.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT07614113 Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children COMPLETED NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING

Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41052472 Successful management of recurrent multiple intracerebral TFE3-rearranged epithelioid hemangioendothelioma with repeated intervention and active surveillance: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025) PMID: 40036206 Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PloS one (2025)

Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161540Advanced Breast Template System K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes

View all 83 devices →

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑