Regulatory Information

 

Axial3D’s 510K cleared AI-driven, cloud-based segmentation system is intended for use for the automated conversion of imaging information from a medical scanner to a 3D output.

The 3D outputs are validated to be used for clinical use and treatment planning for orthopaedic, orthopaedic trauma, cardiovascular, and maxillofacial applications and should be used in conjunction with other diagnostic tools and expert clinical judgement.

The Axial3D Cloud Segmentation Service can be used to create digital 3D files or to fabricate physical replicas using additive manufacturing methods when printed in conjunction with the materials and printers below. Other printers may be used to create 3D anatomical models for demonstration and educational purposes with Axial3D Cloud-Based Segmentation Service, however, these have not been validated by Axial3D and the quality of such printers cannot be guaranteed.

For Axial3D’s complete QIH approval, you can reference the links below.

• K222745
• K221511

Please also refer to the Axial3D Operator Manual for additional instructions and guidance for printing and processing 3D models.

 

Printer Manufacturer	Technology	Model	Material	Applications
Formlabs	Vat Polymerization	Form 3B	Standard White V4	Orthopedics
			FLGPWH04	Cardiovascular
				Maxillofacial
			Standard Draft V2	Orthopedics
			FLDRGR02	Cardiovascular
				Maxillofacial
			Standard Clear V4	Cardiovascular
			FLGPCL04
			Flexible 80A V1	Cardiovascular
			FLFL8001
Stratasys	Polyjet	J750	Agilus, VeroBlackPlus, VeroClear, VeroCyan, VeroGrey, VeroMagenta, VeroPureWhite, VeroYellow	Orthopedics
				Cardiovascular
				Maxillofacial
	Polyjet	J5 MediJet	VeroVividTM Cyan, VeroVividTM Magenta, VeroVividTM Yellow, DraftWhite, MED610, MED615RGD, VeroUltraClearTMS, ElasticoTM Clear	Orthopedics
				Cardiovascular
				Maxillofacial
HP	Multi-jet Fusion	HP580	Nylon PA12	Orthopedics
				Cardiovascular
				Maxillofacial
	Multi-jet Fusion	HP540	Nylon PA12	Orthopedics
				Cardiovascular
				Maxillofacial