Identity
- Trade Name
- Loop-X FDA UDI
- Generic Name
- Multi-modality diagnostic x-ray system, mobile FDA UDI
- Device Name
- 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
- Model / Reference
- 2 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
- 19120075320129 FDA UDI
- 510(k) Number
- K234067 FDA UDI
- FDA Product Code
- OWB FDA UDI
- GMDN Term
- Multi-modality diagnostic x-ray system, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Multi-modality diagnostic x-ray system, mobile
Loop-X by medPhoton GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality diagnostic x-ray system, mobile.
- Loop-X — medPhoton GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- medPhoton GmbH
Sources (1)
- FDA UDI 82443462-1361-40d4-9280-0fdd08468959 35 fields · synced May 31, 2026