Cleared Traditional

K050296 - ECLIPSE TREATMENT PLANNING SYSTEM

K050296 is the FDA 510(k) clearance for ECLIPSE TREATMENT PLANNING SYSTEM by Varian Medical Systems. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K050296 · Varian Medical Systems · Radiology device
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Nov 2005
Decision
269d
Days
Class 2
Risk

K050296 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 (Palo Alto, US). The FDA issued a Cleared decision on November 3, 2005 after a review of 269 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K050296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date November 03, 2005
Days to Decision 269 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
162d slower than avg
Panel avg: 107d · This submission: 269d
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 K050296.
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