Cleared Special

K172163 - Eclipse Treatment Planning System

K172163 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 Special 510(k) pathway after a 28-day FDA review.

K172163 · Varian Medical Systems, Inc. · Radiology device
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Aug 2017
Decision
28d
Days
Class 2
Risk

K172163 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 August 15, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K172163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2017
Decision Date August 15, 2017
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K172163.
Prelude
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K170750 · Brainlab AG · Aug 2017
Eclipse Treatment Planning System
K170969 · Varian Medical Systems, Inc. · Jul 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