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FDA 510(k)

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

K-Number: K234067 · 2025-03-28

ApplicantMedphoton GmbH
Decision Date2025-03-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) is a medical device manufactured by Medphoton GmbH. It received FDA 510(k) clearance on 2025-03-28 under approval number K234067. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)?

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Medphoton GmbH. The 510(k) number is K234067.

When was ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) approved by the FDA?

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) received FDA 510(k) clearance on 2025-03-28, under approval number K234067.

What company makes ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)?

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) is manufactured by Medphoton GmbH.

What is the FDA product code for ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)?

The FDA product code for ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) is OWB.

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Other Devices by Medphoton GmbH

K161400ImagingRing System K191267ImagingRing System on Rails K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X

Related Devices (Code: OWB)

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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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