Ikoengelo

FDA 510(k) K061006 · Ikoetech, LLC

Substantially Equivalent

510(k) numberK061006

Submission

Device name
Ikoengelo
Applicant
Ikoetech, LLC
Houston, TX, US
Received
April 11, 2006
Decision date
June 5, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPQ – System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Specialty
Radiology

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More from Varian Medical Systems, Inc.

510(k)DeviceDecision
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Questions and answers

When was Ikoengelo cleared by the FDA?

Ikoengelo (K061006) received a 510(k) decision of Substantially Equivalent on June 5, 2006, 55 days after the submission was received.

What is the product code of K061006?

The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.