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FDA 510(k)

ImagingRing System

K-Number: K161400 · 2016-12-08

ApplicantMedphoton GmbH
Decision Date2016-12-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ImagingRing System is the device name listed in this FDA 510(k) record. The listed applicant is Medphoton GmbH. It received FDA 510(k) clearance on 2016-12-08 under 510(k) 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. The listed applicant is Medphoton GmbH. The 510(k) number is K161400.

When did ImagingRing System receive FDA 510(k) clearance?

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

Who is the listed applicant for ImagingRing System?

The FDA 510(k) record lists Medphoton GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImagingRing System?

The FDA product code for ImagingRing System is IYE.

Other records listing Medphoton GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XK191267ImagingRing System on Rails

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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