Cleared Special

SIMULIX EVOLUTION

K033470 · Nucletron Corporation · Radiology
Feb 2004
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K033470 is an FDA 510(k) clearance for the SIMULIX EVOLUTION, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on February 4, 2004, 93 days after receiving the submission on November 3, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K033470 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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