Cleared Traditional

K090706 - ONCENTRA SIMULATION 2.3

K090706 is an FDA 510(k) clearance for ONCENTRA SIMULATION 2.3, manufactured by Nucletron Corporation. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K090706 · Nucletron Corporation · Radiology device
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Jun 2009
Decision
90d
Days
Class 2
Risk

K090706 is an FDA 510(k) clearance for the ONCENTRA SIMULATION 2.3. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on June 15, 2009 after a review of 90 days - within the typical 510(k) review window.

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.

View all Nucletron Corporation devices

FDA 510(k) Submission Details - K090706

510(k) Number K090706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date June 15, 2009
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 34
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K090706.
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · Nucletron Corp. · Sep 2007
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · Nucletron Corporation · Oct 2005
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005
SIMULIX EVOLUTION
K033470 · Nucletron Corporation · Feb 2004
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002