Cleared Traditional

ARIA Radiation Therapy Management System (18.1)

K242463 · Varian Medical Systems, Inc. · Radiology
Dec 2024
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K242463 is an FDA 510(k) clearance for the ARIA Radiation Therapy Management System (18.1), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 13, 2024, 116 days after receiving the submission on August 19, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K242463 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2024
Decision Date December 13, 2024
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050