Cleared Special

SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM

K052361 · Nucletron Corporation · Radiology
Oct 2005
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K052361 is an FDA 510(k) clearance for the SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM, 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 October 24, 2005, 56 days after receiving the submission on August 29, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K052361 FDA.gov
FDA Decision Cleared 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

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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