DTX Studio Clinic

K203156 · Nobel Biocare AB · LLZ · Nov 20, 2020 · Radiology

Device Facts

• Record ID: K203156
• Device Name: DTX Studio Clinic
• Applicant: Nobel Biocare AB
• Product Code: LLZ · Radiology
• Decision Date: Nov 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Device Story

Software interface for dental/medical practitioners; analyzes 2D/3D imaging data (intraoral/extraoral X-rays, CBCT, intraoral scans). Transforms raw imaging data into visualized diagnostic workspaces; enables distance/angular measurements, airway volume segmentation, and alignment of surface scans with CBCT data for implant planning. Produces visual diagnostic reports and design inputs for dental restorations. Used in clinical settings; operated by dental professionals. Integrates with DTX Studio Core database and 3rd party Patient Management Systems (PMS) via VDDS/OPP protocols. Output assists clinicians in diagnostic evaluation, treatment planning, and patient communication; facilitates accurate implant positioning and restorative design.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation conducted per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Moderate Level of Concern) and ISO 13485:2016/ISO 14971:2012 standards.

Technological Characteristics

Software-based visualization tool; runs on Windows 10 64-bit, macOS Mojave, and macOS Catalina. Supports DICOM, STL, NXA, PLY formats. Connectivity via network/cloud (DTX Studio Core) and 3rd party PMS (VDDS/OPP protocols). Features include airway segmentation, automatic IOR sorting, and virtual tooth setup algorithms. Compliant with EN IEC 62304:2006.

Indications for Use

Indicated for dental and craniomaxillofacial patients requiring diagnostic imaging analysis and treatment planning support. Used by dental/medical practitioners to acquire, manage, transfer, and analyze 2D/3D imaging data (X-rays, CT/CBCT, intraoral scans) to support diagnostic processes and restorative treatment planning.

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

• CliniView (K162799)

Reference Devices

• DentiqAir (K183676)
• DTX Studio Implant (K163122)

Submission Summary (Full Text)

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November 20, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Nobel Biocare AB % Vladislavs Mihailovs Regulatory Affairs Manager Medicim NV Stationsstraat 102 Mechelen, Antwerp 2800 BELGIUM

Re: K203156

Trade/Device Name: DTX Studio Clinic Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 13, 2020 Received: October 22, 2020

Dear Vladislavs Mihailovs:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K203156

Device Name DTX Studio Clinic

Indications for Use (Describe)

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

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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### 8. 510(k) Summary

#### I. Submitter

Submitted by: Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800, Belgium Establishment Registration No. 3005739655 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Göteborg, SE-411 17, Sweden Establishment Registration No. 9611992 Date Prepared: 13 October 2020

#### II. Device

Name of Device: DTX Studio Clinic Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: 2 Product Code: LLZ

#### III.Predicate Device

Substantial equivalence is claimed to the following device:

#### Main predicate

Predicate Device: CliniView Predicate 510(k): K162799 Compay: Palodex Group Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

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#### Reference device 1:

Predicate Device: DentiqAir Predicate 510(k): K183676 Compay: 3D Industrial Imaging Co., Ltd Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

#### Reference device 2:

Predicate Device: DTX Studio Implant Predicate 510(k): K163122 Company: Nobel Biocare AB Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

#### IV. Device Description

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intraoral and extraoral X-rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

#### V. Indications for Use

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

#### VI. Comparison of Technological Characteristics

The subject and predicate devices are software-based data visualization tools which allow for transfer of medical images and enhancement with intention to support diagnostic process and treatment planning of craniomaxillofacial patients.

#### Summary comparison of technological similarities and differences

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The subject device DTX Studio Clinic and the predicate device CliniView share following characteristics:

- . Clinical Use - intended to support the diagnostic and treatment planning process of craniomaxillofacial anatomical area
- . Clinical image data import and acquisition from supported devices, data visualization, distance and angular measurements
- Image enhancement - image filter application, annotations
- Patient data management features

DTX Studio Clinic is different from the predicate device CliniView as follows:

- Airway volume segmentation (same with the reference device DentigAir (K183676)) ●
- Intraoral radiograph (IOR) automatic image sorting to an FMX template
- DTX Studio Clinic ioscan module a dedicated intraoral scanner workspace for ● acquisition of 3D intraoral models in STL, NXA, PLY file formats (classification NOF, 872.3661)
- Alignment of intra-oral scan or dental cast scan STL files with (CB)CT data for ● accurate implant planning (same with the reference device DTX Studio Implant (K163122))
- . Scan request - scheduling and reservation of supported imaging modalities for image acquisition. The predicate device CliniView controls settings of imaging modalities for image acquisition, whereas DTX Studio Clinic does not control connected imaging modalities.
- Image data and patient file import from 3rd party Patient Management Systems (PMS) ●
- Adding dental implant shapes to DICOM data for treatment planning (same with the ● reference device DTX Studio Implant (K163122))
- Virtual tooth setup - an algorithm for calculation and visualization of a 3D tooth model for missing teeth (same as with the reference device DTX Studio Implant (K163122))

A comparison of the subject and predicate devices is provided in the table below.

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| Criteria | DTX Studio Clinic<br>(subject device) | CliniView (predicate device)<br>K162799 | DentiqAir (reference<br>device for airway<br>segmentation<br>functionality)<br>K183676 | DTX Studio Implant<br>(reference device for<br>dental implant<br>planning<br>functionality)<br>K163122 | Comments |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for<br>Use Statement | DTX Studio Clinic is a<br>software program for the<br>acquisition, management,<br>transfer and analysis of<br>dental and<br>craniomaxillofacial image<br>information, and can be<br>used to provide design input<br>for dental restorative<br>solutions. It displays and<br>enhances digital images<br>from various sources to<br>support the diagnostic<br>process and treatment<br>planning. It stores and<br>provides these images<br>within the system or across<br>computer systems at<br>different locations. | CliniView software program is<br>indicated for general dental and<br>maxillofacial diagnostic imaging. It<br>controls capture, display, enhancement,<br>and saving of digital images from<br>various digital imaging systems. It<br>stores and communicates these images<br>within the system or across computer<br>systems at distributed locations. | DentiqAir is a<br>software application<br>for the visualization<br>and segmentation of<br>imaging information<br>of the oral-<br>maxillofacial region.<br>The imaging data<br>originates from<br>medical scanners such<br>as CT or CBCT<br>scanners. The dental<br>professionals' planning<br>data may be exported<br>from DentiqAir and<br>used as input data for<br>CAD or Rapid<br>Prototyping Systems. | DTX Studio Implant is<br>a software interface for<br>the transfer and<br>visualization of 2D and<br>3D image information<br>from equipment such<br>as a CT scanner for the<br>purposes of supporting<br>the diagnostic process,<br>treatment planning and<br>follow-up in the dental<br>and cranio-<br>maxillofacial regions.<br>DTX Studio Implant<br>can be used to support<br>guided implant surgery<br>and to provide design<br>input for and review of<br>dental restorative<br>solutions. The results<br>can be exported to be<br>manufactured. | Different -<br>See<br>discussion<br>below |
| Classification<br>code | LLZ, NOF | LLZ | LLZ | LLZ | Same |
| Input<br>data/Image<br>acquisition | DICOM image data<br>volumes, 2D and 3D images<br>such as (CB)CT scans and | 2D (CB)CT scans and 2D images such<br>as OPG/ panorex images, | DICOM image data<br>volumes,<br>cephalometric images, | DICOM data from<br>(CB)Ct scanner | Different -<br>See |
| | 2D images such as | cephalometric images intra-oral images<br>and clinical pictures | optical impression<br>data visualization | | discussion<br>below |
| | OPG/panorex images, | | | | |
| | acquisition of X-Ray | | | | |
| | images from intra-oral | | | | |
| | sensors, cephalometric | | | | |
| | images, intra-oral images | | | | |
| | and clinical pictures. | | | | |
| | STL, NXA, PLY files from | | | | |
| | intraoral and optical<br>scanner. | | | | |
| Output data | Data is stored locally or in<br>remotely accessible<br>database in the network<br>(DTX Studio Core). | Images and related data are stored in<br>the CliniView database or remotely<br>accessible database in the network.<br>Image export | A "Project" consisting<br>of planning data<br>(including<br>segmentation<br>information), volume<br>data, and optical<br>surface data may be<br>exported and imported<br>in a 3DII proprietary<br>format. | Export surgical<br>template design for<br>centralized production<br>in Nobel Biocare<br>facilities.<br><br>Export surgical<br>template design<br>(proprietary or open<br>format) to be<br>manufactured<br><br>Export treatment plan<br>for dental restoration<br>design in DTX Studio<br>design | Different -<br>See<br>discussion<br>below |
| | 2D and 3D image export<br>(DICOM image data<br>volumes, 2D and 3D images<br>such as (CB)CT scans and<br>2D images such as<br>OPG/panorex images,<br>acquisition of X-Ray<br>images from intra-oral<br>sensors, cephalometric<br>images, intra-oral images<br>and clinical pictures.), STL,<br>PLY, NXA file export.<br><br>Export implant or<br>restorative treatment plan<br><br>Diagnostic findings report<br>export. | | | | |
| Image | Enhancement (image filter | Enhancement (image filter | Image color | Enhancement (image | Different - |
| processing | application), annotations,<br>measurements (distance and<br>angular, volume and surface<br>area for data segmentation),<br>import/export.<br><br>Airway volume<br>segmentation.<br>Alignment of surface scans,<br>such as intra-oral or dental<br>cast scans .STL/.PLY files<br>with (CB)CT data for<br>accurate implant planning | application), annotations,<br>measurements (distance and angular),<br>import/export and printing. | manipulation tools,<br>view manipulation<br>tools, 3D volume<br>clipping, length and<br>angle measurements,<br>segmentation of<br>anatomical structures,<br>airway segmentation,<br>segmentation of<br>mandible and fossa | filter application),<br>annotations,<br>measurements<br>(distance and angular).<br><br>Alignment of intra-oral<br>scan or dental cast scan<br>STL files with (CB)CT<br>data for accurate<br>implant planning. | See<br>discussion<br>below |
| Software<br>Features | Scan data:<br><br>The software can directly<br>acquire images from<br>supported imaging<br>modalities or allow manual<br>import of images by import<br>dialog. The data can be<br>manually adjusted with the<br>wizard editor.<br><br>The data can be also<br>imported from 3rd party<br>patient management<br>systems via standard<br>protocol - VDDS, or via<br>Nobel Biocare proprietary<br>OPP protocol. | Scan data:<br><br>The software can directly acquire<br>images or allow manual import of<br>images by drag and drop or import<br>dialog. The data can be manually<br>adjusted with the panorama curves<br>editor | Scan data:<br><br>Software allow only<br>manual import of<br>images. | Scan data:<br><br>Software allow only<br>manual import of<br>images. | Different -<br>See<br>discussion<br>below |
| | Diagnostic: | Diagnostic: | Diagnostic: | Diagnostic: | Different -<br>See |
| The diagnostic module<br>allows to review and<br>diagnose 2D and 3D image<br>data as well as clinical<br>images. The user can apply<br>image filters and can<br>measure length, angles and<br>HU units.<br>The software allows to<br>compare 3D images and 2D<br>intraoral images in the same<br>workspace<br>Visualization of airways,<br>volume segmentation,<br>volume measurement and<br>maximum constriction point<br>determination. | The diagnostic module allows to<br>review and diagnose 2D and 3D (by<br>using 3rd party applications) image<br>data. The user can apply image filters<br>and can measure length, print function,<br>diagnosis<br>The software allows to compare 3D<br>(by using 3rd party applications)<br>images and 2D images in one<br>workspace. | The user can apply<br>image filters and can<br>measure length and<br>angles.<br>Segmentation of<br>anatomical structures. | The user can apply<br>image filters and can<br>measure length, angles<br>and HU units. | discussion<br>below | |
| Intraoral scanner:<br>DTX Studio ioscan module<br>is a user interface<br>supporting a dental optical<br>impression system, more<br>specifically an intraoral<br>scanning device.<br>Review of STL, PLY, NXA<br>type data within dedicated<br>workspace | N/A | N/A | N/A | Different –<br>See<br>discussion<br>below | |
| Automatic sorting<br>algorithm:<br>Intraoral radiograph (IOR)<br>automatic image sorting to | N/A | N/A | N/A | Different –<br>See<br>discussion<br>below | |
| | an FMX template (dental<br>X-ray image layout). | | | | |
| | Implant Planning:<br>Functionality for implant<br>planning treatment. Adding<br>dental implant shapes to<br>DICOM data for treatment<br>planning. | N/A | N/A | Implant planning:<br>Adding an implant,<br>abutments and anchor<br>pins to a planning.<br>Surgical template<br>calculation from intra-<br>oral surface data. | Different -<br>See<br>discussion<br>below |
| | Virtual tooth setup:<br>Algorithm calculates and<br>visualizes a 3D tooth shape<br>for a missing tooth position,<br>based on a set of indicated<br>landmarks and the loaded<br>intra-oral scan | N/A | N/A | N/A | Different -<br>See<br>discussion<br>below |
| Operating<br>system<br>requirements | Windows 10 64-bit<br>macOS Mojave, macOS<br>Catalina | Windows 7<br>Professional/Ultimate/Enterprise<br>SP1 (32 or 64-bit)<br>Windows 8/8.1<br>Professional/Enterprise (32 or<br>64-bit)<br>Windows 10 | Windows 7,8 and<br>10(64bit) | PC – Windows based<br>MAC - OS | Different -<br>See<br>discussion<br>below |
| Recommended<br>hardware<br>requirements | CPU: quad-core of 2.8 GHz<br>or more (such as Intel Core<br>i5 or i7)<br>RAM: 8GB<br>Graphics card with support<br>of OpenGL 3.3 and 2GB<br>memory or more (4GB or<br>more for 4K displays)<br>HDD: 10GB of free space | HDD ≥ 8 GB<br>RAM ≥ 4GB<br>CPU Intel Core i3 or better | CPU : Intel i3 Dual<br>Core<br>RAM : 2 GB<br>HDD : 2 GB free<br>space<br>Graphic card that<br>supports<br>DirectX 10.1<br>Monitor: 1600 x 900<br>pixels | CPU: dual-core of<br>3GHz or more<br>RAM: 8GB<br>Graphics card with<br>support of OpenGL 3.3<br>and 1GB memory or<br>more (2GB or more for<br>4K displays)<br>HDD: 5GB of free<br>space | Different -<br>See<br>discussion<br>below |

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| Monitor: FullHD<br>(1920x1080) or higher | resolution<br>Monitor: FullHD<br>(1920x1080) or higher |
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#### Discussion

#### Similarities:

The subject device DTX Studio Clinic and primary predicate device CliniView (K162799) have the same Intended Use and share most software functions/features. Other software features such as airway volume segmentation or implant planning are shared with the reference predicate device DentiqAir (K183676) and DTX Studio Implant (K163122). Difference in indications for use and software features are discussed below.

Both softwares utilize a graphic user interface with a large 3D based main window, several dedicated workspaces for various imaging modalities, several visualization and image processing tools for the purpose of facilitating diagnostic and treatment planning process for craniomaxillofacial anatomical area.

Both DTX Studio Clinic and CliniView share functionality of clinical image data import and acquisition from supported devices, data visualization, distance and angular measurements.

#### Differences:

#### Indications for Use

The Indications for Use statement between the subject and the primary predicate devices (K162799) are primarily the same. Minor differences in wording do not alter the intended therapeutic use of the subject device.

Both DTX Studio Clinic and the primary predicate device CliniView allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image within the system (locally) or across computer systems at distributed locations. DTX Studio Clinic allows transfer of images and patient data (store and retrieval) to and from the DTX Studio Core database, thus making the data available at different locations. The primary predicate Clini View (K162799) allows to store and retrieve patient data and related image data in a local or central database called Data Warehouse.

Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete cranio-maxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire cranio-maxillofacial area, as a support for the diagnostic process.

One of the differences within the Indications for Use statement is that the subject device can provide design input data for restorative solutions to 3rd party software or software from DTX Studio Ecosystem (DTX Studio Implant and DTX Studio Lab), but it does not provide

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functionality of designing restorations within the software itself. Hence, this difference does not impact the therapeutic use of the device.

Another difference in wording within the Indications for Use statement is support of treatment planning. Because diagnostic process naturally leads to a treatment, software contains functionality of storing patient files and their diagnostic history. It is also possible to compare different set of imaging data, for example pre-op and post-op of craniomaxillofacial situation. Because subject device does not contain functionality to signal a necessity of treatment and the decision of treatment planning and execution is taken by the user as a logical outcome of diagnostic process, this difference in wording does not impact therapeutic use of software and it's Intended Use.

#### Differences in software features/functionality

#### Airway volume segmentation

Another difference between subject device and the predicate device is that DTX Studio Clinic allows volume segmentation of indicated airway on the image data, volume measurements and constriction point determinations. Such functionality is available in the reference device DentiqAir (K183676).

The difference between the subject device and the reference device is that the latter is intended for segmentation and measurements of various anatomical structures and specifically segmentation of mandible and fossa, while the segmentation and measurements in the subject device are intended and limited to airway.

#### Automatic image sorting algorithm

In addition, DTX Studio Clinic has an algorithm for automatic sorting of acquired or imported intra-oral X-Ray images. The user has an option to disable this feature. Automatically sorted images are displayed in an FMX layout in software intraoral workspace window. This functionality detects tooth numbers in accordance with either the FDI or the Universal tooth numbering system and sorts it accordingly. This function does not provide any image enhancement or processing capabilities and does not intended to be a part of diagnostic process. This functionality is related to workflow improvement of software, as well as an effecti…