Cleared Special

K152393 - Eclipse Treatment Planning System

K152393 is an FDA 510(k) clearance for Eclipse Treatment Planning System, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 25-day FDA review.

K152393 · Varian Medical Systems, Inc. · Radiology device
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Sep 2015
Decision
25d
Days
Class 2
Risk

K152393 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 September 18, 2015 after a review of 25 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

FDA 510(k) Submission Details - K152393

510(k) Number K152393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date September 18, 2015
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MUJ Device Classification - Class 2, Special Controls

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 212
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K152393.
Panther StereoSeed
K143514 · Prowess, Inc. · Dec 2015
CORVUS Radiation Therapy Planning System
K151469 · Best Nomos · Nov 2015
Onrad Treatment System
K152488 · Accuray Incorporated · Sep 2015
syngo VSim
K151887 · Siemens Medical Solutions USA, Inc. · Sep 2015
QuickPlan
K151560 · Siris Medical · Sep 2015
Leksell GammaPlan
K151666 · Elekta Instrument AB · Sep 2015