Cleared Special

K041403 - ECLIPSE WITH AAA

K041403 is the FDA 510(k) clearance for ECLIPSE WITH AAA by Varian Medical Systems. It is a Class 2 Radiology device (product code MUJ) cleared through the Special 510(k) pathway after a 61-day FDA review.

K041403 · Varian Medical Systems · Radiology device
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Jul 2004
Decision
61d
Days
Class 2
Risk

K041403 is an FDA 510(k) clearance for the ECLIPSE WITH AAA. 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 July 26, 2004 after a review of 61 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 devices

Submission Details

510(k) Number K041403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2004
Decision Date July 26, 2004
Days to Decision 61 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
46d faster than avg
Panel avg: 107d · This submission: 61d
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 K041403.
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · Varian Medical Systems · Nov 2005
VITESSE 2.0
K051497 · Varian Medical Systems, Inc. · Jul 2005
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269 · Elekta Instrument AB · Sep 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · Siemens Medical Solutions USA, Inc. · Nov 2002
ACQPLAN 5.0
K013644 · Philips Medical Systems, Inc. · Sep 2002