Loop-X P04-2

GUDID 19120075320075

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

Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Full-body CT/general-purpose fluoroscopic x-ray system Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile Multi-modality diagnostic x-ray system, mobile

• Primary Device ID: 19120075320075
• NIH Device Record Key: 930c9e61-bf77-45d0-9cee-7ca53070c7cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loop-X
• Version Model Number: 1
• Catalog Number: P04-2
• Company DUNS: 300376801
• Company Name: medPhoton GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	19120075320075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203281

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: 2021-03-30
• Device Publish Date: 2021-03-22

Devices Manufactured by medPhoton GmbH

• 19120075320068 - ImagingRing m: 2021-03-30 Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to a
• 19120075320075 - Loop-X: 2021-03-30Loop-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.
• 19120075320075 - Loop-X: 2021-03-30 Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluor
• 19120075320013 - ImagingRing: 2019-04-23
• 19120075320037 - ImagingRing: 2019-04-23