Axial3D Cloud Segmentation Service

Basic Information

• Brand Name: Axial3D Cloud Segmentation Service
• Primary DI: 05065007075005
• Version / Model: 1
• Company Name: AXIAL MEDICAL PRINTING LIMITED
• Labeler DUNS: 219447389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-17
• Public Version: 2
• Public Version Date: 2024-08-20
• Public Version Status: Update
• Public Device Record Key: 8efcc082-b080-4b12-a35f-05e832ae87b5

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05065007075005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221511	000