Cleared Traditional

K133227 - SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING

K133227 is an FDA 510(k) clearance for SMART SEGMENTATION - KNOWLEDGE BASED CO..., manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K133227 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
144d
Days
Class 2
Risk

K133227 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, Inc. (Palo Alto, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 144 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, Inc. devices

FDA 510(k) Submission Details - K133227

510(k) Number K133227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date March 14, 2014
Days to Decision 144 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
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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 548
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K133227.
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
K140823 · Varian Medical Systems, Inc. · Jun 2014
MOBIUS3D
K140660 · Mobius Medical Systems, LP · Jun 2014
ARIA RADIATION THERAPY MANAGEMENT
K133572 · Varian Medical Systems, Inc. · Apr 2014
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
K132908 · Medtec, Inc. · Mar 2014
BIOMARC FIDUCIAL MARKER
K132064 · Carbon Medical Technologies, Inc. · Feb 2014
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
K132935 · Siemens Medical Solutions USA, Inc. · Feb 2014