K Number
K231607
Device Name
Axial3D Cloud Segmentation Service
Date Cleared
2024-01-24

(237 days)

Product Code
Regulation Number
892.2050
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.
More Information

No reference devices were used in this submission.

Unknown
The summary mentions "image processing" and "segmentation" which can be performed using AI/ML, but it does not explicitly state that AI/ML is used. There is no mention of AI, DNN, or ML in the provided text, nor are there details about training or test sets typically associated with AI/ML development.

No
The device is described as an image segmentation service used for treatment planning and diagnostic purposes, not for direct therapeutic intervention.

Yes

The "Intended Use / Indications for Use" section states: "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." It also states: "Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment." These statements explicitly indicate its use for diagnostic purposes.

No

The device description explicitly states that the service can transfer imaging information as a "3D printed physical model," and the performance studies include validation of "printing of physical replica models," indicating a hardware component (the 3D printer) is involved in the intended use of the device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Axial3D Cloud Segmentation Service processes medical imaging data (DICOM files from CT/CTA scans) to create digital output files or physical replicas. This process is based on analyzing images of the body, not on analyzing samples taken from the body.
  • Intended Use: The intended use is for treatment planning and/or diagnostic purposes by providing physical replicas or digital files derived from imaging data. This is distinct from performing tests on biological samples.

The device falls under the category of medical image processing and segmentation software, which is a different regulatory classification than IVDs.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed tomograghy (CT), CT Angiography (CTA)

Anatomical Site

Orthopedic, Maxillofacial, Cardiovascular

Indicated Patient Age Range

Adults. The output file or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications.

Intended User / Care Setting

Hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Axial3D performed software design verification and validation testing on all three software components of the device and the software documentation for a Moderate Level of Concern software in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2015.

Axial3D has conducted software verification and validation, in accordance with the FDA quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002. All software requirements and risk analysis have been successfully verified and traced.

Axial3D Cloud Seqmentation Service device has been validated for its intended use to determine substantial equivalence to the predicate device. Measurement accuracy and comparisons were performed and confirmed to be within specification of +/- .7mm.

Validation of printing of physical replica models was performed and demonstrated to be accurate when using any of the compatible printers.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

+/- .7mm

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K221511

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Axial Medical Printing Limited % Sujith Shetty Executive Vice President Maxis Medical LLC 3031 Tisch Way, Suite 1010 San Jose, California 95128

January 24, 2024

Re: K231607

Trade/Device Name: Axial3D Cloud Segmentation Service Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 28, 2023 Received: January 2, 2024

Dear Sujith Shetty:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231607

Device Name Axial3D Cloud Segmentation Service

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Axial3D. The word "axial" is in a bold, dark blue font, with a small teal diamond above the "i". To the right of "axial" is a superscript "3D". Below the logo is the tagline "Patient data made real" in a teal font.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

510 (k) number: K231607

Applicant Information

Axial Medical Printing Limited 17A Ormeau Avenue Belfast BT2 8HD United Kingdom Tel: +44 (0)28 90183590

Contact Person

Joanne Flatley, QA/RA Lead

Device Information

Trade NameAxial3D Cloud Segmentation Service
Common NameMedical image management and processing system
Classification number892.2050
Regulatory ClassII
Product CodeLLZ

Predicate Device

Table 1 - Predicate Device

NameManufacturer510(k)#
Axial3DAxial Medical Printing
LimitedK221511

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Image /page/4/Picture/0 description: The image contains the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller, superscript font. Below the logo is the tagline "Patient data made real" in a teal sans-serif font.

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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.

Indications for 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 output file 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 in conjunction with other diagnostic tools and expert clinical judgment.

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Image /page/5/Picture/1 description: The image is a logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller, lighter blue font. Below the word "axial" is the phrase "Patient data made real" in a teal color.

Comparison of Intended Use to Predicate Devices

Table 2 - Predicate Device Comparison: Intended Use

| Attribute | Axial3D Cloud
Segmentation Service
(Proposed Device) | Axial3D Cloud
Segmentation Service
(Predicate Device) | Comparison |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Axial Medical Printing
Limited | Axial Medical Printing
Limited | Equivalent |
| Device Name | Axial3D Cloud
Segmentation Service | Axial3D Cloud
Segmentation Service | Equivalent |
| Device Trade or
Proprietary Name | Axial3D Cloud
Segmentation Service | Axial3D Cloud
Segmentation Service | Equivalent |
| 510(k) Number | K231607 | K221511 | N/A |
| Device
Regulation
Name: | Medical image
management and
processing system | Medical image
management and
processing system | Equivalent |
| Device
Regulation
Number: | 21 CFR 892.2050 | 21 CFR 892.2050 | Equivalent |
| Device Product
Code: | LLZ | LLZ | Equivalent |
| Device
Classification
FDA: | Class II | Class II | Equivalent |
| Indication for 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
output file or physical
replica may also be used
for pediatrics between the | 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 | Similar. The proposed
device includes
specifications for ,
orthopedic,
maxillofacial, and
cardiovascular
applications for adults
and children greater
than 12 years old and
in cardiovascular
applications for children
greater than 2 months
of age population in
which 3D models can
be provided for based
on clinical imaging. |
| Attribute | Axial3D Cloud
Segmentation Service
(Proposed Device) | Axial3D Cloud
Segmentation Service
(Predicate Device) | Comparison |
| | ages of 12 and 21 years
of age in cardiovascular
applications.
Axial3D Cloud
Segmentation Service
should be used in
conjunction with other
diagnostic tools and
expert clinical judgment. | and cardiovascular
applications.
Axial3D Cloud
Segmentation Service
should be used in
conjunction with other
diagnostic tools and
expert clinical judgment. | |
| 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 output file 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 in | 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. | Similar. The proposed
device includes
specifications for ,
orthopedic,
maxillofacial, and
cardiovascular
applications for adults
and children greater
than 12 years old and
in cardiovascular
applications for children
greater than 2 months
of age population in
which 3D models can
be provided for based
on clinical imaging. |
| Attribute | Axial3D Cloud
Segmentation Service
(Proposed Device) | Axial3D Cloud
Segmentation Service
(Predicate Device) | Comparison |
| | conjunction with other
diagnostic tools and
expert clinical
judgment. | | |
| Target Populate | Adult for all indications
children 12 to 21 for
cardiovascular indication | Adult | Similar |
| Method of Use | Used in conjunction with
other diagnostic tools and
expert clinical judgement. | Used in conjunction with
other diagnostic tools and
expert clinical judgement. | Equivalent |
| Image Modality | Computed tomograghy
(CT),
CT Angiography (CTA) | Computed tomograghy
(CT),
CT Angiography (CTA) | Equivalent |
| Environment | Hospital | Hospital | Equivalent |
| OTC or
Prescription
Device | Prescription Use | Prescription Use | Equivalent |
| Level of Concern | Moderate | Moderate | Equivalent |
| V&V | Complies with FDA
Guidance Requirement | Complies with FDA
Guidance Requirement | Equivalent |

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Image /page/6/Picture/0 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the superscript "3D". Below the logo is the tagline "Patient data made real" in a teal font.

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Image /page/7/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a teal diamond shape above the "i". To the right of "axial" is the superscript "3D". Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font.

Comparison of Technological Characteristics to the Predicate Device and Reference Device

| Attribute | Axial3D Cloud
Segmentation
Service
(Proposed Device) | Axial3D Cloud Segmentation
Service
(Predicate Device) | Comparison |
|-------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------|------------|
| Method of Use | software interface | software interface | Equivalent |
| Computer Platform and
Operating System | Internet Explorer 11
or equivalent | Internet Explorer 11 or
equivalent | Equivalent |

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Image /page/8/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the number "3D" in a smaller, superscript font. Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font.

| Attribute | Axial3D Cloud
Segmentation
Service
(Proposed Device) | Axial3D Cloud Segmentation
Service
(Predicate Device) | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------------|
| Supported Modalities | CT and CTA | CT and CTA | Equivalent |
| Image registration | Yes | Yes | Equivalent |
| Segmentation Features | A combination of
automated tools
with smart editing
tools | A combination of automated
tools with smart editing tools | Equivalent |
| View Manipulation and
Volume Rendering | Yes | Yes | Equivalent |
| Regions and Volumes of
Interest (ROI) | ● Orthopedic
● Maxillofacial
● Cardiovascular | ● Orthopedic
● Maxillofacial
● Cardiovascular | Equivalent |
| Region/volume of interest
measurements and size
measurements | Yes | Yes | Equivalent |
| Region/Volume
Quantification | Yes | Yes | Equivalent |

Performance Data

Nonclinical testing

Axial3D performed software design verification and validation testing on all three software components of the device and the software documentation for a Moderate Level of Concern software in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2015.

Axial3D has conducted software verification and validation, in accordance with the FDA quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002. All software requirements and risk analysis have been successfully verified and traced.

Axial3D Cloud Seqmentation Service device has been validated for its intended use to determine substantial equivalence to the predicate device. Measurement accuracy and comparisons were performed and confirmed to be within specification of +/- .7mm.

Validation of printing of physical replica models was performed and demonstrated to be accurate when using any of the compatible printers.

Conclusions:

The Axial3D Cloud Segmentation Service with its expanded indication for use to include, orthopedic, maxillofacial, and cardiovascular cases in adults and children

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Image /page/9/Picture/1 description: The image contains the logo for Axial3D. The logo consists of the word "axial" in a bold, dark blue font, with a small teal diamond shape above the "i". To the right of "axial" is the superscript "3D", also in dark blue. Below the main logo is the tagline "Patient data made real" in a teal color.

greater than 12 years old is substantially equivalent to the predicate device cleared under K221511.

The technological aspects of the device have not changed from the original 510(k) approval. Validation of the printers and 3D model process has been performed and no safety or efficacy concerns are changed by the expanded indication for use.