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510(k) Data Aggregation
K Number
K231607Device Name
Axial3D Cloud Segmentation Service
Manufacturer
Date Cleared
2024-01-24
(237 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Axial Medical Printing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which 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 and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications.
Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.
Device Description
Axial3D Cloud Segmentation Service is a secure, highly available cloud-based image processing, segmentation, and 3D modelling framework for the transfer of imaging information either as a digital file or as a 3D printed physical model.
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K Number
K232841Device Name
Axial3D Insight
Manufacturer
Date Cleared
2023-11-15
(62 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Axial Medical Printing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file.
The Axial3D Insight output file can be used for the fabrication of the output file using additive manufacturing methods.
The output file or physical replica can be used for treatment planning.
The output file or physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial, and cardiovascular applications.
Axial3D Insight should be used with other diagnostic tools and expert clinical judgment.
Device Description
Axial3D Insight is a secure, highly available cloud-based image processing, segmentation, and 3D modelling framework for the transfer of imaging information either as a 3D printed physical model.
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K Number
K222745Device Name
Axial3D Insight
Manufacturer
Date Cleared
2023-07-03
(294 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Axial Medical Printing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Axial3DInsight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file.
The Axial3DInsight output file can be used for the fabrication of the output file using additive manufacturing methods.
The output file or physical replica can be used for treatment planning.
The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.
Axial3DInsight should be used with other diagnostic tools and expert clinical judgment.
Device Description
Axial3D Insight is a secure, highly available cloud-based image processing, segmentation and 3D modelling framework for the transfer of imaging information either as a 3D printed physical model.
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K Number
K221511Device Name
Axial3D Cloud Segmentation Service
Manufacturer
Date Cleared
2022-06-23
(30 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Axial Medical Printing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 judgment.
Device Description
Axial3D Cloud Segmentation Service is a secure, highly available cloud based image processing, segmentation and 3D modeling framework for the transfer of imaging information to either a digital file or as a 3D printed physical model.
Axial3D Cloud Segmentation Service is made up of a number of component parts, which allow the production of patient-specific 1:1 scale replica models, either as a digital file or as a 3D printed physical model.
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