Mimics Thoracic Planner

K251964 · Materialise NV · LLZ · Mar 12, 2026 · Radiology

Device Facts

• Record ID: K251964
• Device Name: Mimics Thoracic Planner
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: Mar 12, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM-compliant medical images. The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis. The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure. The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Device Story

Software for pre-procedural planning of pulmonary/thoracic surgeries; inputs include DICOM medical images and pre-segmented 3D anatomical models. Clinicians use software to visualize anatomy, evaluate lesions, define resections, and assess surgical pathways. Provides tools for anatomical measurements, 3D visualization, and annotation. Used in clinical settings by physicians; integrated with SurgiCase Online for case/user management. Output is a digital plan used as reference during procedures; does not modify plans intra-operatively. Benefits include improved surgical preparation and visualization of patient-specific anatomy.

Clinical Evidence

Bench testing only. Quantitative verification compared subject device outputs (segment/subsegment volumes, lesion diameters) against predicate device (K183105) and synthetic data. Results showed 0.0% deviation for volumes and 0.1 mm tolerance for lesion diameter calculations. No clinical data presented.

Technological Characteristics

Cloud-based software; C++, Python, C#, JavaScript/TypeScript. Integrates with SurgiCase Online MDDS. Inputs: DICOM images and 3D models. Features: 3D visualization, measurement, and annotation tools. Verification performed per FDA software guidance. No physical materials; software-only device.

Indications for Use

Indicated for clinicians to review, analyze, and plan pulmonary or thoracic procedures (e.g., segmentectomy, lobectomy, pneumectomy) using DICOM-compliant medical images and 3D models. Used for pre-procedural visualization, measurement, and annotation, and post-op analysis. Not for intra-operative modification of plans.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Mimics Medical (K183105)

Reference Devices

• Mimics Cardiac Planner (K233217)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

Materialise N.V.
Victoria Becheva
Regulatory Affairs Specialist
Technologielaan 15
Leuven, 3001
Belgium

Re: K251964
March 12, 2026

Trade/Device Name: Mimics Thoracic Planner
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: February 12, 2026
Received: February 13, 2026

Dear Victoria Becheva:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251964 - Victoria Becheva
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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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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

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K251964 - Victoria Becheva
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K251964

Device Name

Mimics Thoracic Planner

Indications for Use (Describe)

The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM-compliant medical images.

The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis.

The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure.

The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K251964 510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.

| Company name | Materialise N.V. |
| --- | --- |
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Principal Contact person | Victoria Becheva |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | [e-mail] |
| Additional contact person | Jenny Jones |
| Contact title | Global Quality & Regulatory Manager, Medical |
| Contact e-mail address | [e-mail] |

## Submission date

The date of the Traditional 510(k) submission is 12 March 2026.

## Submission information

| Trade Name | Mimics Thoracic Planner |
| --- | --- |
| Common Name | Image processing system |
| Classification Name | System, Image processing, Radiological |
| Regulation | 21 CFR 892.2050 (Medical image management and processing system) |
| Product code | LLZ |

Materialise N.V.

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# Description and functioning of the device

The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM compliant medical images. The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis. The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure. The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement. The Mimics Thoracic Planner is an online planning software, which allows the clinician to review and adjust a plan for a surgical procedure of the pulmonary/thoracic anatomy based on DICOM images and 3D models. The planned procedure may be one of the following: segmentectomy, lobectomy, pneumectomy, etc. The Mimics Thoracic Planner software guides the clinician through different steps of the workflow, where the relevant information, like virtual 3D models of anatomy, images and measurements are presented. The software enables the clinician to review the anatomy, evaluate the target lesion, define the resection and assess the pathway to remove the resection. The software provides the tools to adjust all predefined measurements, and to perform custom measurements. The software is integrated with a Medical Device Data System, which is responsible for case management and user management.

During the procedure, the intra-op step should only be used to visualize the pre-operative plan. Mimics Thoracic Planner is not intended to be used to modify the pre-operative plan during surgery.

# Predicate Devices

The primary predicate device to which substantial equivalence is claimed:

| Trade or proprietary or model name | Mimics Medical |
| --- | --- |
| 510(k) number | K183105 |
| Decision date | 27 March 2019 |
| Classification product code | LLZ |
| Manufacturer | Materialise N.V. |

The reference device:

| Trade or proprietary or model name | Mimics Cardiac Planner |
| --- | --- |
| 510(k) number | K233217 |
| Decision date | 12 February 2024 |
| Classification product code | LLZ |
| Manufacturer | Materialise N.V. |

Materialise N.V.

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Materialise N.V.
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# Indications for Use

The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM compliant medical images.

The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis.

The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure.

# Technological Characteristics

Comparison if technological characteristics with the primary predicate device (Mimics Medical K183105)

The subject device Mimics Thoracic Planner employs similar fundamental technologies as Mimics Medical.

The similarities include:

- Indications for Use
Both the predicate and the subject device are intended to be used as planning software using medical images as input. Both devices are intended to perform measurements. Both devices are intended to be used in conjunction with other diagnostic tools and expert clinical judgement.

- Device Functionality
Both the subject and primary predicate devices include tools for visualizing and measuring based on medical images and 3D models. These tools enable the user to analyze the anatomy, plan the procedure, and use the output file as a reference during the intervention.

- Virtual 3D models used during planning
As such the geometric accuracy of the virtual models used in the subject device is the same as in the primary predicate device.

- Software technology
Both subject and primary predicate device are developed using the same underlying Materialise technology.

- Device design and development process
Both primary predicate and subject device software are manufactured by the same company (Materialise NV), the subject device follows the same development cycle and testing procedures as the primary predicate device. The verification and validation of primary predicate and subject device has been done following the same procedures and workflows.

- Process in which the software is used
In a generic planning process, both devices can be used by medical professionals to plan treatment options.

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- Testing
Both the predicate device and subject device have undergone quantitative and qualitative testing of the system.

The following technological differences exist between the subject and the predicate device:

- Indications for use
The indications for use of the subject device are a subset of the indications for use of the primary predicate device.

- Device Functionality
While the primary predicate device requires medical images as input and will provide segmentation tools to create 3D models based on the medical images, the subject device is scoping this part out for the clinician and is requiring the 3D models as input next to the medical images, so the clinician shouldn't spend his time segmenting 3D models from images. This segmentation task will be prepared by Materialise in the primary predicate device Mimics Medical (K183105). This process of preparing some part by Materialise as input for the planning software is exactly as such in the predicate device Mimics Cardiac Planner (K233217).

- Virtual 3D models used during planning: The segmentation step of creating the 3D models from images is omitted in the subject device and is expected as input to the subject device. The virtual models used as input to the subject device are in fact created in the primary predicate

- Software technology
While the primary predicate device is a desktop Windows software which is run locally on a computer of the clinician, the subject device is cloud software. This enables the software to be used on multiple platforms without installation. So, while on the back-end both subject and primary predicate device are using the same Materialise technology, the front-end of the application is developed in other programming languages due the environment the software should run in. The front-end programming language is the same as the predicate Mimics Cardiac Planner (K233217) device.

Comparison if technological characteristics with the predicate device (Mimics Cardiac Planner K233217)

The Mimics Thoracic Planner employs similar fundamental technologies as Mimics Cardiac Planner. Technological similarities include:

- Device functionality
Both the subject and reference devices share much of the software functionality, including visualization of 3D models, image visualization, measurement tools, and report generation

- Virtual 3D models used during planning:
Both devices, expect created virtual 3D anatomical models as an input. For both virtual models are created in Mimics Medical (K183105).

- Software technology
Both subject and predicate device are based on the same cloud technology and are developed by the same team in Materialise, sharing the same code libraries. Both products are integrated with the same Medical

Materialise N.V.

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Device Data System, SurgiCase Online (which is responsible for the case management, user management, etc.).

- Device design and development process
Both predicate and subject software are manufactured by the same company (Materialise NV), the subject device originates from the same code base as the predicate device; and follows the same development cycle and testing procedures as the predicate device. The verification and validation of predicate and subject device has been done following the same procedures and workflows.

- Process in which the software is used
Mimics Thoracic Planner is used in a similar process as Mimics Cardiac Planner, where images are uploaded on an online Case Management system, where segmentation on this data is performed as a service by Materialise. The output of this service is then used as input for the Mimics Thoracic Planner (subject device) and Mimics Cardiac Planner (predicate device).

The following technological differences exist between the subject and the reference device:

- Device functionality
While from a feature perspective the tools in the software are very similar, they are applied to a different field (Cardiac vs Thoracic).

A device comparison table of the subject, primary predicate, and predicate devices is provided below.

| | Subject device
Mimics Thoracic Planner
K251964 | Primary Predicate device
Mimics Medical
K183105 | Predicate Device
Mimics Cardiac Planner
K233217 |
| --- | --- | --- | --- |
| Trade name | Mimics Thoracic Planner | Materialise Mimics Medical | Mimics Cardiac Planner |
| Common name | Image processing system | Image processing system | Image processing system |
| Manufacturer | Materialise NV | Materialise NV | Materialise NV |
| Classification | Product code: LLZ (21 CFR 892.2050)
Classification Panel: Radiology
Device Class: Class II | Product code: LLZ (21 CFR 892.2050)
Classification Panel: Radiology
Device Class: Class II | Product Code: LLZ (21 CFR 892.2050)
Classification Panel: Radiology
Device Class: Class II |
| Indications for use | The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM compliant medical images.
The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis. | Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning.
The Mimics Medical output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. | Mimics Cardiac Planner is intended to be used as a pre-procedural planning software to screen and plan structural heart and vascular procedures based on DICOM compliant medical images.
Mimics Cardiac Planner allows the clinician to visualize, measure, annotate and edit pre-procedural plan data.
The software can be used to evaluate the sizing, positioning and delivery |

Materialise N.V.

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Materialise N.V.
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| | The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure. The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement. | The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics Medical should be used in conjunction with expert clinical judgement. | pathway of structural heart and vascular devices. Mimics Cardiac Planner should be used in conjunction with other diagnostic tools and expert clinical judgement. |
| --- | --- | --- | --- |
| Imaging modality | DICOM compliant imaging information | Medical Imaging information | DICOM compliant imaging information |
| Design | Mimics Thoracic Planner is a workflow-based software interface for the transfer of medical images to an output planning file. The system provides visualization and measurement tools to enable the user to plan the procedure. Mimics Thoracic Planner reads DICOM compliant medical images from a medical scanner together with the 3D models and landmarks. The software provides different methods to visualize the anatomical structures. Based on the medical images and/or 3D reconstruction measurements are created and visualized. All this will be saved in a digital output file. The output file is intended to be used in conjunction with other diagnostic tools and expert clinical judgment. | Software interface and image segmentation system for the transfer of medical imaging information to an output file. Software for measuring and treatment planning. The physical replicas or anatomical models that can be created with Mimics Medical can have a variety of clinical uses. Besides the clearly non-diagnostic applications (training, education, patient communication), the diagnostic applications of 3D printed models can be divided into two categories: 1. Diagnostic application equivalent with the use of a virtual model 2. Diagnostic application specific to the physical aspect of a 3D printed model (templating) The 3D printed model generated from the Mimics Medical output file plays a role as a supplementary tool only, next to traditional tools for diagnosis and treatment planning, and must be used under supervision of a clinical expert. | Mimics Cardiac Planner is a workflow-based software interface for the transfer of medical images to an output planning file. The system provides visualization and measurement tools to enable the user to plan the procedure. Mimics Cardiac Planner reads DICOM compliant medical images from a medical scanner together with the 3D models and landmarks. The software provides different methods to visualize the anatomical structures. Based on the medical images and/or 3D reconstruction measurements are created and visualized. All this will be saved in a digital output file. The output file is intended to be used in conjunction with other diagnostic tools and expert clinical judgment. |
| Programming language | C++, Python, C#, JavaScript (TypeScript) | C++ | C++, Python, C#, JavaScript (TypeScript) |
| Operating system | Microsoft Windows, MAC OS, iOS | Microsoft Windows | Microsoft Windows, MAC OS, iOS |

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Materialise N.V.

| Function | Import of images and segmented models
Pre-surgical planning through
Analyze anatomy: anatomical measurements, 3D and image visualization options
Plan resection: resection related views, tools and measurements to select the resection.
Plan/keep track of surgical cuts: views and tools to indicate surgical cuts.
Intra-op guidance: visualize the plan during the intervention.
Functionality is organized into a user guided workflow for better user experience.
Integrated with a Medical Device Data System, SurgiCase Online (which is responsible for case management, user management, etc). | Image segmentation
Treatment planning
Measurements
Processing to output file
Generation of physical replicas which can be used for diagnostic purposes | Import of images, segmented models and landmarks
Pre-surgical planning through
Analyze anatomy: anatomical measurements, 3D and image visualization options
Plan device: Device selection and positioning and device related measurements
Plan delivery: assessing access pathway and access measurements
Output : intra-op guidance for fluoro angles
Functionality is organized into a user guided workflow for better user experience.
Integrated with a Medical Device Data System, SurgiCase Online (which is responsible for case management, user management, etc). |
| --- | --- | --- | --- |
| Testing | Software testing
Software verification testing
Software validation testing | Software verification and validation
Segmentation test
Orthopedic and CMF
Segmentation test
Cardiovascular
Validation of compatibility with a set of 3D printers with the purpose to generate physical replicas which can be used for diagnostic purposes | Software testing
Software verification testing
Software validation testing |

# Conclusion

Following the comparison between the subject and primary predicate device, and between subject and predicate device, it can be concluded that the abovementioned technological differences between the subject and primary predicate device do not impact the safety and effectiveness of the subject device for the proposed indications for use as they are covered using a predicate device with matching characteristics in the areas where the subject device differs from the predicate, as well as by the verification and validation.

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# Performance Data

Software verification and validation were performed, and documentation was provided following the FDA guidance "Content of Premarket Submissions for Device Software Functions." This includes verification against defined requirements, and validation against user needs.

Non-clinical performance testing was performed to verify that Mimics Thoracic Planner provides visualization, measurement, and planning functionality equivalent to the FDA-cleared predicate device, Mimics Medical (K183105). Quantitative functions, including segment and subsegment volumes, and lesion measurements were verified with results meeting predefined acceptance criteria.

Detailed overview on software verification and validation for automated features:

| Automated or Semi-automated Feature | Description | Test Method | Conclusion |
| --- | --- | --- | --- |
| (sub)segment volume (L) | The volume of each selected segment or subsegment. | Quantitative comparison against predicate device: The volume displayed in Mimics Thoracic Planner must match exactly (0.0% deviation) the volume displayed by the predicate device for the same segment(s)/subsegment(s). | The segment volume displayed equals (0.0% deviation) the volume of the same segment in the predicate device. |
| (sub)segment volume percentage (%) | The volume percentage of each selected segment or subsegment. | Quantitative comparison against predicate device: The total volume is independently checked against the total calculated in the predicate, to confirm correct summation and display. | The volume percentage and total volume displayed match the predicate device values with 0.0% deviation. |
| Lesion mean and max diameter (mm) | The mean and maximum diameters of the selected lesion(s).The mean diameter is computed using a sphere-fitting algorithm.The maximum diameter is determined from the maximum internal distance of the 3D object of the lesion. | Quantitative comparison: Compare results against three spheres of known diameters, chosen to represent clinically relevant size ranges based on the NCCN Guidelines V8.2025 - Non-small cell lung cancer. Compare results from five diverse clinical cases against a separately implemented calculation of the same algorithm. | The mean and maximum diameter displayed match the synthetic data with 0.0% deviation.The mean and maximum diameter displayed match the separately implemented algo with 0.1 mm tolerance. |

# Summary

The characteristics that determine the functionality and performance of the subject device Mimics Thoracic Planner is substantially equivalent to the device cleared under Mimics Medical (K183105), the primary predicate device. The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device. Therefore, it can be concluded that the Mimics Thoracic Planner is substantially equivalent to the predicate device.

Materialise N.V.