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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 the device name listed in this FDA 510(k) record. The listed applicant is Medphoton GmbH. It received FDA 510(k) clearance on 2025-03-28 under 510(k) 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. The listed applicant is Medphoton GmbH. The 510(k) number is K234067.

When did ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) receive FDA 510(k) clearance?

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 510(k) number K234067.

Who is the listed applicant for ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)?

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 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.

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.

K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XK191267ImagingRing System on RailsK161400ImagingRing System

Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, 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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