Cleared Traditional

K170969 - Eclipse Treatment Planning System

K170969 is the FDA 510(k) clearance for Eclipse Treatment Planning System by Varian Medical Systems, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K170969 · Varian Medical Systems, Inc. · Radiology device
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Jul 2017
Decision
96d
Days
Class 2
Risk

K170969 is an FDA 510(k) clearance for the Eclipse Treatment Planning System. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 5, 2017 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K170969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date July 05, 2017
Days to Decision 96 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 130
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K170969.
syngo.via RT Image Suite
K173635 · Siemens Medical Solutions USA, Inc. · Jan 2018
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
K170750 · Brainlab AG · Aug 2017
Eclipse Treatment Planning System
K172163 · Varian Medical Systems, Inc. · Aug 2017
Pinnacle Radiation Therapy Planning System
K170086 · Philips Medical Systems (Cleveland), Inc. · Feb 2017
syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Eclipse Treatment Planning System
K152393 · Varian Medical Systems, Inc. · Sep 2015