# K203281: Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X

- Pathway: 510(k) (Traditional)
- Applicant: Medphoton GmbH
- Decided: Dec 22, 2020 after 46 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003266 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142740: Ziehm Vision RFD 3D, Ziehm Imaging GmbH (2015) Summary page 7.

## Most influential descendants
- K234067: ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (2025), 0 descendants of its own

## Indications for use
The IRm is a mobile X-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The IRm provides an interface that can be used by system integrators for integration of the IRm with image guidance systems such as surgical navigation systems.

Source page: https://510kreport.com/device/K203281
Methodology: https://510kreport.com/methodology