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FDA 510(k)

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X

K-Number: K203281 · 2020-12-22

ApplicantMedphoton GmbH
Decision Date2020-12-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is a medical device manufactured by Medphoton GmbH. It received FDA 510(k) clearance on 2020-12-22 under approval number K203281. 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 Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Medphoton GmbH. The 510(k) number is K203281.

When was Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X approved by the FDA?

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X received FDA 510(k) clearance on 2020-12-22, under approval number K203281.

What company makes Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is manufactured by Medphoton GmbH.

What is the FDA product code for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

The FDA product code for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is OWB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Medphoton GmbH

K161400ImagingRing System K191267ImagingRing System on Rails K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Related Devices (Code: OWB)

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Official Source

View on FDA Database →

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