FDA 510(k)

ImagingRing System

K-Number: K161400 · 2016-12-08

Decision Date2016-12-08

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ImagingRing System is a medical device manufactured by Medphoton GmbH. It received FDA 510(k) clearance on 2016-12-08 under approval number K161400. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImagingRing System?

ImagingRing System is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Medphoton GmbH. The 510(k) number is K161400.

When was ImagingRing System approved by the FDA?

ImagingRing System received FDA 510(k) clearance on 2016-12-08, under approval number K161400.

What company makes ImagingRing System?

ImagingRing System is manufactured by Medphoton GmbH.

What is the FDA product code for ImagingRing System?

The FDA product code for ImagingRing System is IYE.

Other Devices by Medphoton GmbH

K191267ImagingRing System on Rails K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.