EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

K241114 · Ewoosoft Co., Ltd. · LLZ · Jul 23, 2024 · Radiology

Device Facts

• Record ID: K241114
• Device Name: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
• Applicant: Ewoosoft Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 23, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

EzDent-i 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. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

Device Story

EzDent-i v3.5 is dental imaging software for acquisition, transfer, editing, display, and storage of medical images; operates on standard PC/network environments. Inputs include 2D images (JPG, BMP), DICOM files from panoramic, cephalometric, and intra-oral sensors/scanners, and intra-oral camera feeds via OpenCV. Software provides tools for linear/angle measurements, brightness/contrast adjustment, nerve canal tracing, and implant library access. Used in dental clinics by trained professionals (dentists/radiologists) to assist in diagnosis and treatment planning. Output is displayed on workstation monitors; supports server/client model for network-wide access. Does not process 3D radiographs but interfaces with Ez3D-i software. Enhancements include dose indicator display, multi-line annotation, and EzUpdater for online distribution. Clinical decision-making remains the responsibility of the clinician; software serves as an adjunctive tool.

Clinical Evidence

Bench testing only. Software verification and validation testing, including measurement accuracy tests, were conducted to confirm performance, functionality, and reliability. The device met all pre-determined pass/fail criteria. Cybersecurity controls were validated per FDA guidance.

Technological Characteristics

Software-only device; no patient contact. Operates on IBM-compatible PCs (Windows 10/11) with network connectivity (wired/wireless). Supports DICOM, JPG, BMP formats. Interfaces with X-ray capture software and OpenCV for image acquisition. Features include image manipulation (brightness, contrast, rotation, zoom), measurement tools (linear, angle), and annotation. Database management via SQL. No 3D processing capability.

Indications for Use

Indicated for trained medical professionals, such as radiologists and dentists, to view and interpret DICOM-compliant maxillofacial radiographic images and to acquire, view, and save 2D images from panoramic, cephalometric, and intra-oral imaging equipment.

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

• EzDent-i/E2/Prora View/Smart M Viewer (v3.4) (K223820)

Reference Devices

• Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069, K231757)
• EzSensor XHD (K232255)

Submission Summary (Full Text)

{0}------------------------------------------------

July 23, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: On the left, there is an emblem representing the Department of Health & Human Services-USA. To the right of the emblem, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is placed within a blue square.

Ewoosoft Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant 18881 Von Karman Ave. STE 160 IRVINE, CA 92612

# Re: K24114

Trade/Device Name: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 6, 2023 Received: June 24, 2024

Dear Priscilla 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 (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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K241114

Device Name EzDent-i/E2/Prora View/Smart M Viewer (v3.5)

#### Indications for Use (Describe)

EzDent-i 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.

EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary (K241114)

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

### 1. Date: 7/22/2024

#### 2. Applicant / Submitter

Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: [phone] Fax: [phone] Contact person: Sunny Lee Email: [e-mail]

### 3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: [phone] Tel: [phone] Email: [e-mail]

### 4. Subject Device:

- Trade/Device Name: EzDent-i/E2/Prora View/Smart M Viewer (v3.5) ●
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Medical Image Management and Processing System ●
- Regulatory Class: Class II
- Product Code: LLZ

### 5. Predicate Device:

- Manufacturer: Ewoosoft Co., Ltd.
- Trade/Device Name: EzDent-i/E2/Prora View/Smart M Viewer (v3.4) ●
- 510k Number: K223820
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Medical Image Management and Processing System ●
- Regulatory Class: Class II ●
- Product Code: LLZ ●

{4}------------------------------------------------

# 6. Device Description:

EzDent-i v3.5 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069, K231757) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

# 7. Indication for use:

EzDent-i 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.

EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

{5}------------------------------------------------

# 8. Substantial Equivalence:

| | Unmodified Device | Modified Device | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | EzDent-i v3.4 | EzDent-i v3.5 | Version Change |
| 510K number | K223820 | K241114 | - |
| Manufacturer | Ewoosoft | Ewoosoft | Same |
| Indications for use | EzDent-i 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.<br>EzDent-i is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i 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.<br>EzDent-i is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | Same |
| Regulatory Number<br>& Common Name | 21 CFR 892.2050<br>Medical image management and processing system | 21 CFR 892.2050<br>Medical image management and processing system | Same |
| Device Class | Class II | Class II | Same |
| Software<br>Documentation<br>Level | Moderate | Basic | Same |
| Technology/Principle<br>of Operation | EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. | EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. | Same |
| management software<br>specifically for digital dental<br>radiography. It also provides<br>server/client model so that the<br>users upload and download<br>clinical diagnostic images and<br>patient information from any<br>workstations in the network<br>environment. | management software<br>specifically for digital dental<br>radiography. It also provides<br>server/client model so that the<br>users upload and download<br>clinical diagnostic images and<br>patient information from any<br>workstations in the network<br>environment. | | |
| EzDent-i supports general image<br>formats such as JPG and BMP<br>for 2D image viewing as well as<br>DICOM format. | EzDent-i supports general image<br>formats such as JPG and BMP<br>for 2D image viewing as well as<br>DICOM format. | | |
| EzDent-i supports the<br>acquisition of dental images by<br>interfacing with OpenCV library<br>to import the intra-oral camera<br>images. It also supports the<br>acquisition of<br>CT/Panoramic/Cephalo/Intra-<br>Oral Sensor images by<br>interfacing with X-ray capture<br>software. | EzDent-i supports the<br>acquisition of dental images by<br>interfacing with OpenCV library<br>to import the intra-oral camera<br>images. It also supports the<br>acquisition of<br>CT/Panoramic/Cephalo/Intra-<br>Oral Sensor images by<br>interfacing with X-ray capture<br>software. | | |
| Platform | IBM-compatible PC or PC<br>network | IBM-compatible PC or PC<br>network | Same |
| Minimum Server PC<br>System | - CPU: Dual-Core Processor<br>@ 3.4GHz | - CPU: Dual-Core Processor<br>@ 3.4GHz | Equivalent |
| | - RAM: 4GB | - RAM: 8GB | Updated PC<br>system |
| | - Display 1280×1024 | - Display 1280×1024 | requirements are<br>intended to better<br>fit the current PC |
| Minimum Client PC<br>System | - CPU: Dual-Core Processor<br>@ 2.7GHz | - CPU: Dual-Core Processor<br>@ 2.7GHz | part market<br>situation for<br>availability. The<br>key requirements |
| | - RAM: 4GB | - RAM: 4GB | such as CPU are<br>not changed thus |
| | - Display 1024×768 | - GPU: Internal or External<br>GPU Supporting<br>OpenGL2.1 | the modifications<br>do not affect |
| | | - Display 1024×768 | substantial<br>equivalence to the |
| Network | Wired or Wireless Network | Wired or Wireless Network | Same |
| | - Wired: 100M ethernet LAN | - Wired: 100M ethernet LAN | |
| | (CAT 5 cable)<br>- Wireless: 802.11n | (CAT 5 cable)<br>- Wireless: 802.11n | |
| Operating System | Microsoft Windows 10,11 | Microsoft Windows 10,11 | Same |
| User Interface | Mouse, Keyboard | Mouse, Keyboard | Same |
| Image Input Sources | Images can be scanned, loaded<br>from digital cameras or card<br>readers, or imported from a<br>radiographic imaging device | Images can be scanned, loaded<br>from digital cameras or card<br>readers, or imported from a<br>radiographic imaging device | Same |
| 32 bit / 64 bit | 32 / 64 bit | 32 / 64 bit | Same |
| Image format | DICOM | DICOM | Same |
| Patient Database<br>Compatibility | SQL | SQL | Same |
| Includes Image<br>Measurement tools | Linear distance, angle | Linear distance, angle | Same |
| Image viewing | Full, side by side, gallery, thumbnail | Full, side by side, gallery, thumbnail | Same |
| Image manipulation | Brightness, contrast, sharpness,<br>inverse, film view, rotate,<br>zooming, whitening, nerve canal<br>tracing, memo | Brightness, contrast, sharpness,<br>inverse, film view, rotate,<br>zooming, whitening, nerve canal<br>tracing, memo | Same |
| Implant module | Generic implant libraries | Generic implant libraries | Same |
| 3D imaging<br>capability | Includes interface to 3D imaging<br>software, Ez3D-i. EzDent-i<br>imaging software does not view,<br>transfer or process 3D<br>radiographs. | Includes interface to 3D imaging<br>software, Ez3D-i. EzDent-i<br>imaging software does not view,<br>transfer or process 3D<br>radiographs. | Same |
| | | | |
| Image annotation | Text, paint, ellipse, pointer,<br>select, draw, magnify, line,<br>rectangle, polygon, ruler,<br>protractor, smile library,<br>smudge, brush, redeye reduction,<br>select region, copy / paste | Text, paint, ellipse, pointer,<br>select, draw, magnify, line,<br>multi-line, rectangle, polygon,<br>ruler, protractor, smile library,<br>smudge, brush, redeye reduction,<br>select region, copy / paste | Equivalent<br>1) [Multi-line]<br>tool, an upgrade to<br>existing [Line] tool<br>is added.<br>2) A tool to<br>directly open<br>Annotation<br>Properties dialog<br>added. The role of<br>the dialog is<br>identical to the<br>annotation settings<br>on the Settings<br>dialog of the<br>unmodified device.<br>Thus, the<br>modifications do<br>not affect<br>substantial<br>equivalence to the<br>predicate device. |
| Distribution of<br>Installation File for<br>Upgrade | USB | USB, EzUpdater | Equivalent<br>Online distribution<br>of installation files<br>supported through<br>EzUpdater.<br>However, the<br>installation process<br>is identical. |
| Customer Support | Manufacturer website, phone<br>number, and e-mail information<br>provided. | Manufacturer website, phone<br>number, and e-mail information<br>provided. | Same<br>(with a tool to<br>access to CS<br>website) |
| Dose Information<br>Display | File information | File information, Dose<br>indicator(if applicable) | Equivalent<br>Dose indicator is<br>added in order to<br>support EzSensor<br>XHD(K232255).<br>However, the role<br>of EzDent-i is not<br>to calculate the |
| | | | information but to<br>visualize the<br>received<br>information into<br>dose indicator.<br>Thus, the key<br>feature, displaying<br>the received value,<br>is identical to the<br>predicate device<br>and the<br>modification does<br>not affect<br>substantial<br>equivalence to the<br>predicate device. |
| Report Management | Create, open, view, edit, delete…