Cleared Traditional

Eclipse Treatment Planning System (v18.0)

K230557 · Varian Medical Systems, Inc. · Radiology
May 2023
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K230557 is an FDA 510(k) clearance for the Eclipse Treatment Planning System (v18.0), 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 May 26, 2023, 87 days after receiving the submission on February 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K230557 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2023
Decision Date May 26, 2023
Days to Decision 87 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