Axial Medical Printing Limited radiology AI products

FDA-cleared K250369

Axial3D Insight

Axial Medical Printing Limited

Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic,...

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

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...

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

Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...

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