Axial Medical Printing Limited radiology AI products

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Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K250369

Axial3D Insight

Axial Medical Printing Limited

Authorized purpose: Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic, maxillofacial, cardiovascular, and treatment-planning workflows; final decisions require expert review.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Trauma, orthopedic, maxillofacial, and cardiovascular anatomy
Decision: 2025-09-18

Quantification and segmentation

FDA-cleared K232841

Axial3D Insight

Axial Medical Printing Limited

Authorized purpose: Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Patient-specific anatomy in trauma, orthopedic, maxillofacial, and cardiovascular applications
Decision: 2023-11-15

Quantification and segmentation

FDA-cleared K222745

Axial3D Insight

Axial Medical Printing Limited

Authorized purpose: Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled orthopedic trauma, orthopedic, maxillofacial, and cardiovascular fields.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Patient-specific anatomy in orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications
Decision: 2023-07-03

Quantification and segmentation