Cleared Special

IKOENGELO, VERSION 2

K083591 · Ikoetech, LLC · Radiology
Dec 2008
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K083591 is an FDA 510(k) clearance for the IKOENGELO, VERSION 2, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Ikoetech, LLC (Houston, US). The FDA issued a Cleared decision on December 29, 2008, 25 days after receiving the submission on December 4, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K083591 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2008
Decision Date December 29, 2008
Days to Decision 25 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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