Cleared Traditional

K132944 - ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

K132944 is an FDA 510(k) clearance for ADVANTAGESIM MD MR PELVIC ORGAN AT RISK..., manufactured by Ge Hungary Kft. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K132944 · Ge Hungary Kft · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
176d
Days
Class 2
Risk

K132944 is an FDA 510(k) clearance for the ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Ge Hungary Kft (Waukesha, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 176 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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.

FDA 510(k) Submission Details - K132944

510(k) Number K132944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2013
Decision Date March 14, 2014
Days to Decision 176 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
69d slower than avg
Panel avg: 107d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 48
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K132944.
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
K132045 · Ge Hungary Kft · Sep 2013
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
K101038 · Acceletronics Digital Imaging, LLC · Aug 2010
ONCENTRA SIMULATION 2.3
K090706 · Nucletron Corporation · Jun 2009
IKOENGELO, VERSION 2
K083591 · Ikoetech, LLC · Dec 2008
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · Nucletron Corp. · Sep 2007
IKOENGELO
K061006 · Ikoetech, LLC · Jun 2006