Cleared Special

K033470 - SIMULIX EVOLUTION

K033470 is an FDA 510(k) clearance for SIMULIX EVOLUTION, manufactured by Nucletron Corporation. The device is a Class 2 Radiology device with product code KPQ cleared through the Special 510(k) pathway after a 93-day FDA review.

K033470 · Nucletron Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
93d
Days
Class 2
Risk

K033470 is an FDA 510(k) clearance for the SIMULIX EVOLUTION. 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 February 4, 2004 after a review of 93 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033470

510(k) Number K033470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date February 04, 2004
Days to Decision 93 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K033470.
IKOENGELO
K061006 · Ikoetech, LLC · Jun 2006
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · Nucletron Corporation · Oct 2005
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
EXOMIO, MODEL 2.0 SP1
K032550 · Medcom GmbH · Sep 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002