Cleared Traditional

K050296 - ECLIPSE TREATMENT PLANNING SYSTEM

K050296 is an FDA 510(k) clearance for ECLIPSE TREATMENT PLANNING SYSTEM, manufactured by Varian Medical Systems. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K050296

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.

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 216
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K050296.
IPLAN RT DOSE
K053584 · Brainlab AG · Jul 2006
P.D
K061440 · .Decimal, Inc. · Jun 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325 · Accuray Incorporated · Sep 2005
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K051941 · Accuray, Inc. · Aug 2005
VITESSE 2.0
K051497 · Varian Medical Systems, Inc. · Jul 2005