Cleared Traditional

Eclipse Treatment Planning System (18.1)

K242378 · Varian Medical Systems · Radiology
Dec 2024
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K242378 is an FDA 510(k) clearance for the Eclipse Treatment Planning System (18.1), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on December 11, 2024, 124 days after receiving the submission on August 9, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K242378 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2024
Decision Date December 11, 2024
Days to Decision 124 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