Cleared Traditional

IKOENGELO

K061006 · Ikoetech, LLC · Radiology
Jun 2006
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K061006 is an FDA 510(k) clearance for the IKOENGELO, 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 June 5, 2006, 55 days after receiving the submission on April 11, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K061006 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2006
Decision Date June 05, 2006
Days to Decision 55 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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