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FDA 510(k)

ImagingRing System on Rails

K-Number: K191267 · 2019-08-01

ApplicantMedphoton GmbH
Decision Date2019-08-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ImagingRing System on Rails is the device name listed in this FDA 510(k) record. The listed applicant is Medphoton GmbH. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191267. 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 on Rails?

ImagingRing System on Rails is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Medphoton GmbH. The 510(k) number is K191267.

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

ImagingRing System on Rails received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191267.

Who is the listed applicant for ImagingRing System on Rails?

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 on Rails?

The FDA product code for ImagingRing System on Rails 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-XK161400ImagingRing System

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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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