ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
Medphoton GmbH
MEDPHOTON GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012631246 | 3012631246 | MEDPHOTON GMBH | 1 | N | 2026-01-01 | Karolingerstrasse 16 Salzburg AT 5020 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 207908 | 1797246486 | K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | OWB | 2025-03-28 |
| 207908 | 1128130925 | K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | OWB | 2020-12-22 |
| 207908 | 1675068750 | K191267 | ImagingRing System on Rails | IYE | 2019-08-01 |
| 207908 | 1612536220 | K161400 | ImagingRing System | IYE | 2016-12-08 |
Product Codes Associated With Registrations#
PMN#
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
MedPhoton GmbH
ImagingRing System On Rails
MedPhoton GmbH
ImagingRing System
MEDPHOTON GMBH
GUDID#
ImagingRing r - The ImagingRing r (ImagingRing on Rails) is an assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
2026-04-21
Mobile Monitor Cart System MMCS - "Mobile Monitor Cart System ""MMCS"":The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room.If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system ""ImagingRing m"" or ""Loop-X®"" (abbreviated Rm) of medPhoton GmbH.The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code."
2025-06-10
Remote Control Charging Cart RCCS - "Remote Control Charging Cart ""RCCS"":The Remote Control Charging Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Remote Control Charging Cart System can be used to hold and move medical equipment (i.e. the ImagingRing m / Loop-X Remote Control Panel) within the building or to position it in the room. It also provides a power supply to operate and charge the ImagingRing m / Loop-X Remote Control Panel.The Remote Control Charging Cart is intended and released as accessory to the ImagingRing m (Loop-X). It is included in the technical documentation and 510(k) premarket submission of the ImagingRing m. Therefore it is registered under the same listing numbers and product code."
2025-06-10
ImagingRing m - ImagingRing m, Version 2:Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
2025-05-28
Loop-X - Loop-X Mobile Imaging Robot:Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
2025-05-28
ImagingRing - 1.1
2018-02-09
ImagingRing - 1.2
2018-10-25
ImagingRing m - Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
2021-03-22
Loop-X - Loop-X Mobile Imaging Robot:Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
2021-03-22