Medphoton GmbH · Class II · Cleared Mar 28, 2025
| K-number | K234067 |
| Device name | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) |
| Applicant | Medphoton GmbH |
| Product code | OWB |
| Device class | Class II |
| Decision date | Mar 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1650 |
The ImagingRing m (Version 2.0) is a mobile x-ray system for 2D planar, fluoroscopic, and 3D imaging in adult and pediatric patients. It is used to visualize anatomic structures such as bone, soft tissue, and metallic implants. The system provides an interface for integration with surgical navigation and image guidance systems.
The Version 2.0 device uses a new x-ray source combined with a software upgrade to achieve higher power settings. The predecessor operated at 40-120 kV; the new device operates at 40-140 kV. Additional features include infrared-guided motion compensation and 3D extended field of view (Multi-slit/Multi-slice) imaging, which were not present in the predicate device.
IEC 62304:2015; IEC 60601-1:2005 + A1:2012; IEC 60601-1-2:2014; IEC 60601-1-3:2008 + A1:2013; IEC 60601-1-6:2010 + A1:2013; IEC 60601-2-28:2017; IEC 60601-2-43:2010/AMD1:2017; IEC 60601-2-54:2009/AMD2:2018.
Cadaver and clinical studies demonstrated that the increased tube voltage (140 kVp versus 120 kVp) does not negatively impact image quality and improves penetration for larger patients and metallic implants. Infrared motion compensation reduces artifacts without increasing radiation dose. Extended FOV imaging enhances anatomical coverage and workflow while maintaining image quality. These enhancements provide clinical benefits while maintaining the same fundamental technological approach, confirming substantial equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov