Cleared Traditional

ONCENTRA SIMULATION 2.3

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

About This 510(k) Submission

K090706 is an FDA 510(k) clearance for the ONCENTRA SIMULATION 2.3, 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 June 15, 2009, 90 days after receiving the submission on March 17, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K090706 FDA.gov
FDA Decision Cleared 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

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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