Cleared Traditional

SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING (K112778) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112778 · Varian Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
94d
Days
Class 2
Risk

K112778 is an FDA 510(k) clearance for the SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on December 29, 2011 after a review of 94 days - within the typical 510(k) review window.

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 K112778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date December 29, 2011
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

All 165
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K112778.
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · Philips Medical Systems (Cleveland), Inc. · Jun 2013
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
K123812 · Siemens Medical Solutions USA, Inc. · Mar 2013
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · Siemens Medical Solutions USA, Inc. · Jun 2012
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
K103606 · Siemens Medical Solutions USA, Inc. · Apr 2011
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
K102671 · Siemens Medical Solutions USA, Inc. · Oct 2010
160MLC OPTION
K092145 · Siemens Medical Solutions USA, Inc. · Sep 2009