Identity
- Trade Name
- Loop-X EUDAMEDFDA UDI
- Generic Name
- Multi-modality diagnostic x-ray system, mobile FDA UDI
- Device Name
- ImagingRing m EUDAMEDLoop-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. FDA UDI
- Model / Reference
- P04-2 EUDAMED1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- P04-2 FDA UDI
- Primary DI / UDI-DI
- 19120075320075 EUDAMEDFDA UDI
- Basic UDI-DI
- 1912007532IRm33 EUDAMED
- Direct Marketing DI
- 19120075320075 EUDAMED
- 510(k) Number
- K203281 FDA UDI
- FDA Product Code
- OWB FDA UDI
- EMDN Code
- Z110312,Z11039009 EUDAMED
- GMDN Term
- Multi-modality diagnostic x-ray system, mobile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multi-modality diagnostic x-ray system, mobile
Loop-X by medPhoton GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality diagnostic x-ray system, mobile.
- Loop-X — medPhoton GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- medPhoton GmbH
Sources (2)
- FDA UDI 930c9e61-bf77-45d0-9cee-7ca53070c7cb 35 fields · synced Jul 17, 2026
- EUDAMED 85e7f166-a88a-4e9f-ae07-a43787fdc769 61 fields · synced Jul 17, 2026