Loop-X Mobile Imaging Robot (Version 2.0)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ImagingRing m EUDAMEDFDA UDI
- Generic Name
- Multi-modality diagnostic x-ray system, mobile FDA UDI
- Device Name
- ImagingRing m EUDAMEDMobile (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. FDA UDIImagingRing 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. FDA UDI
- Model / Reference
- P04-1 EUDAMED1 FDA UDI2 FDA UDI
- Description
- 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. FDA UDIImagingRing 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. FDA UDI
Identifiers
- Catalog Number
- P04-1 FDA UDI
- Primary DI / UDI-DI
- 19120075320068 EUDAMEDFDA UDI19120075320112 FDA UDI
- Basic UDI-DI
- 1912007532IRm33 EUDAMED
- Direct Marketing DI
- 19120075320068 EUDAMED
- FDA Product Code
- OWB FDA 510(k)FDA UDI
- EMDN Code
- Z110312,Z11039009 EUDAMED
- GMDN Term
- Multi-modality diagnostic x-ray system, mobile FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Loop-X Mobile Imaging Robot (Version 2.0) is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during medical procedures. It combines mobile robotic capabilities with fluoroscopic imaging to enhance precision and flexibility in interventional radiology, cardiology, and orthopedics.
This system is supplied as a reusable medical device, intended for use in clinical settings such as operating rooms, catheterization labs, and interventional radiology suites. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance, MDD, and MDR authorizations. The device operates within MRI-safe parameters where applicable and is available in configurations corresponding to the listed FEI and registration numbers for regulatory tracking.
Frequently asked questions
What types of medical procedures is the Loop-X Mobile Imaging Robot primarily designed to support, and why is mobility important in these settings?
The Loop-X Mobile Imaging Robot is designed for real-time imaging during interventional procedures in radiology, cardiology, and orthopedics. Its mobility allows it to be positioned precisely in operating rooms, catheterization labs, and interventional radiology suites, enhancing flexibility and accessibility for complex procedures where static imaging systems may be limiting.
Is the Loop-X Mobile Imaging Robot reusable, and if so, what considerations should be taken into account during its use and maintenance?
Yes, the Loop-X Mobile Imaging Robot is supplied as a reusable medical device. Since it is intended for repeated use, strict adherence to manufacturer guidelines for cleaning, disinfection, and maintenance is critical to ensure sterility, functionality, and patient safety. Proper training of staff on these protocols is essential to avoid contamination or mechanical failure.
How does the regulatory approval process for this device differ from other imaging systems, and what does the Class II designation imply?
The Loop-X Mobile Imaging Robot holds FDA 510(k) clearance, MDD, and MDR authorizations, indicating it has undergone rigorous review to demonstrate substantial equivalence to a predicate device. The Class II designation under FDA regulations means it poses moderate risk and requires compliance with specific controls, including performance standards and post-market surveillance, to ensure safety and effectiveness.
What does the presence of multiple FEI numbers and registration numbers indicate about the regulatory tracking of this device?
The multiple FEI (Firm Establishment Identifier) and registration numbers reflect the device’s regulatory tracking across various configurations, models, or variants of the Loop-X Mobile Imaging Robot. These identifiers help authorities and healthcare providers identify specific versions, ensure compliance with regulatory requirements, and manage recalls or updates efficiently.
How does the device’s MRI-safe parameter compliance benefit clinical workflows in hybrid operating rooms?
The Loop-X Mobile Imaging Robot’s MRI-safe parameters allow it to be used in hybrid operating rooms where both fluoroscopic imaging and MRI are required. This compatibility streamlines workflows by enabling seamless integration with MRI systems, reducing patient transfer risks, and improving procedural efficiency for complex cases requiring multimodal imaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K234067 | Class II | Active |
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Manufacturer
- Manufacturer
- medPhoton GmbH
Sources (4)
- FDA 510(k) K234067 24 fields · synced Sep 18, 2026
- FDA UDI fd889ba5-27e0-4697-963a-fba7115aa248 34 fields · synced May 29, 2026
- FDA UDI da142e57-2502-4b19-b4ce-17b7ab21b731 35 fields · synced May 30, 2026
- EUDAMED e8d4d336-41cd-4262-894e-33d37457d1d0 61 fields · synced Jul 9, 2026