Axial3D Cloud Segmentation Service

GUDID 05065007075005

Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgement.

AXIAL MEDICAL PRINTING LIMITED

Custom-made organ/bone anatomy model

• Primary Device ID: 05065007075005
• NIH Device Record Key: 8efcc082-b080-4b12-a35f-05e832ae87b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axial3D Cloud Segmentation Service
• Version Model Number: 1
• Company DUNS: 219447389
• Company Name: AXIAL MEDICAL PRINTING LIMITED
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: false
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com
• Phone: +4402890183590
• Email: j.mcgarry@axial3d.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065007075005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221511

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2022-11-25
• Device Publish Date: 2022-11-17