Loop-X P04-2

GUDID 19120075320129

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.

medPhoton GmbH

Multi-modality diagnostic x-ray system, mobile

• Primary Device ID: 19120075320129
• NIH Device Record Key: 82443462-1361-40d4-9280-0fdd08468959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loop-X
• Version Model Number: 2
• Catalog Number: P04-2
• Company DUNS: 300376801
• Company Name: medPhoton GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120075320129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234067

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [Loop-X]

• 19120075320075: Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray co
• 19120075320129: Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray co