Cleared Special

K052361 - SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM

K052361 is an FDA 510(k) clearance for SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM, 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 56-day FDA review.

K052361 · Nucletron Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
56d
Days
Class 2
Risk

K052361 is an FDA 510(k) clearance for the SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM. 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 October 24, 2005 after a review of 56 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K052361

510(k) Number K052361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date October 24, 2005
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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.
JAN VAN LOCHEM

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 K052361.
IKOENGELO, VERSION 2
K083591 · Ikoetech, LLC · Dec 2008
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · Nucletron Corp. · Sep 2007
IKOENGELO
K061006 · Ikoetech, LLC · Jun 2006
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