Dentiq3D

K160666 · 3D Industrial Imaging Co., Ltd. · LLZ · Oct 5, 2016 · Radiology

Device Facts

• Record ID: K160666
• Device Name: Dentiq3D
• Applicant: 3D Industrial Imaging Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Oct 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Device Story

Dentiq3D is a dental imaging software platform for 3D visualization and analysis of volume data. It accepts DICOM-compliant images from CT, panorama, cephalometric, and intraoral imaging equipment. The software transforms these inputs using GPU-accelerated 3D visualization, multi-planar reconstruction (MPR), and 2D analysis tools. Key functions include canal tracing, implant simulation, volume segmentation, and airway measurement. Used in clinical settings by radiologists and dentists, the software provides diagnostic tools to assist in treatment planning and simulation. Healthcare providers use the output—visualizations, measurements, and reports—as an adjunct to standard radiology practices to inform clinical decision-making. The device benefits patients by enabling precise visualization and planning for maxillofacial procedures.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to establish performance, functionality, and reliability. The device passed all tests based on pre-determined pass/fail criteria.

Technological Characteristics

Software-only device; no patient contact. Operates on standard computer platforms. Features GPU-accelerated 3D visualization, MPR, volume segmentation, and measurement tools. Supports DICOM standard for image data. No life-sustaining functions.

Indications for Use

Indicated for trained medical professionals (radiologists, dentists) to view, interpret, and analyze DICOM-compliant maxillofacial radiographic images (CT, panorama, cephalometric, intraoral) for diagnostic purposes.

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

• Ez3D Plus by EWOOSOFT Co., Ltd. (K152746)

Reference Devices

• InVivo Dental by Anatomage Inc. (K123519)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 5, 2016

3D Industrial Imaging Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 IRVINE CA 92620

Re: K160666 Trade/Device Name: Dentig3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 15, 2016 Received: September 20, 2016

Dear Ms. Chung:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Oaks

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160666

Device Name

Dentiq3D

Indications for Use (Describe)

Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) |
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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

### 1. Date: 09/15/2016

### 2. Applicant / Submitter

3D Industrial Imaging Co., Ltd. 413 Institute of Computer Technology, Seoul National University, Daehak-dong, Gwanak-gu, Seoul, Republic of Korea Tel. [phone]

Contact person: Jin Sa Kim/ Manager, Regulatory Affairs Team

#### 3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine, CA 92620 Tel: [phone] Fax: [phone] Email: [e-mail]

#### 4. Trade/Proprietary Name:

Dentiq3D

#### 5. Common Name:

Radiological Imaging Software

#### 6. Classification:

System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)

#### 7. Device Description:

Dentiq3D is a dental image software platform for the 3D visualization and analysis of volume data. Dentig3D is optimized for analyzing volume data from CT scan and enables users to examine volume data through 3D visualization, 2D analysis, and various MPR

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functions to manipulate CT images. The functions include canal tracing, implant simulation, volume segmentation and airway measurement.

The following are the major functions of Dentiq3D.

- Visualizes CT volume data ●
- Supports various types of data
- Measures 3D object
- Analyzes and filters volume data
- Publishes various forms of report
- 3D visualization by using GPU
- Loads and saves project files
- Restores (Undo) or repeats (Redo) tasks based on operation history
- Supports a user-friendly interface

## 8. Indication for use:

Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

Dentig3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization. 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

## 9. Predicate Device:

- · Primary Predicate Device: Ez3D Plus by EWOOSOFT Co., Ltd. (K152746)
- · Reference Predicate Device: InVivo Dental by Anatomage Inc. (K123519)

## 10. Substantial Equivalence:

Dentiq3D described in this 510(k) has the same intended use and similar technical characteristics as Ez3D Plus (K152746) by EWOOSOFT Co., Ltd and InVivo Dental (K123519) by Anatomage, Inc.

The subject device and predicate device are substantially equivalent, having the same indications for use, the same principle of operation, and similar functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, 3D image construction, image edit, measurements and manipulation.

Comparing to InVivo Dental (K123519), the differences are such that Dentig3D lacks the capability to fabricate implant surgical guides and has no functions to create orthodontic tracing analysis using 3D volume data.

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Any differences between the predicate device and the proposed device are not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and performance tests, we conclude that the proposed device is substantially equivalent in performance to existing legally marketed devices.

## 11. Technological Characteristics:

Dentig3D is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.

## 12. Performance Data:

Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the subject device. The device passed all of the tests based on pre-determined Pass/Fail criteria.

## 13. Conclusion:

The subject device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the Dentiq3D described in this submission is substantially equivalent to the predicate device.