AccessGUDID - DEVICE: Loop-X (19120075320129)

GUDID

Device Identifier (DI) Information

Brand Name: Loop-X
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P04-2
Company Name: medPhoton GmbH

Primary DI Number: 19120075320129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300376801 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65365	Multi-modality diagnostic x-ray system, mobile	A mobile assembly of diagnostic x-ray devices intended to acquire, display and process images from any part of the body (full-body) incorporating the techniques of more than one x-ray imaging modality, typically including real-time fluoroscopy, two-dimensional (2D) radiography, and computed tomography (CT); it is not a single-modality system. It typically consists of a gantry with x-ray tubes and opposing detectors that rotate rapidly, console, monitor and patient bed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWB	Interventional Fluoroscopic X-Ray System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234067	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82443462-1361-40d4-9280-0fdd08468959
Public Version Date: June 05, 2025
Public Version Number: 1
DI Record Publish Date: May 28, 2025