Cleared Special

K091492 - MODIFICATION TO ECLIPSE TREATMENT PLANN...

K091492 is the FDA 510(k) clearance for MODIFICATION TO ECLIPSE TREATMENT PLANN... by Varian Medical Systems, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K091492 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
29d
Days
Class 2
Risk

K091492 is an FDA 510(k) clearance for the MODIFICATION TO 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 June 18, 2009 after a review of 29 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 K091492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date June 18, 2009
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K091492.
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · Varian Medical Systems, Inc. · Sep 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · Siemens Medical Solutions USA, Inc. · Jun 2010
LEKSELL GAMMAPLAN
K090972 · Elekta Instrument AB · Jul 2009
PINNACLE3 SMARTARC
K090808 · Philips Medical Systems, Inc. · Apr 2009
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008
ECLIPSE TREATMENT PLANNING SYSTEM
K073020 · Varian Medical Systems, Inc. · Dec 2007