(58 days)
No
The document describes image processing and management features but does not mention AI, ML, or any related technologies.
No.
The device is described as dental imaging software intended to provide diagnostic tools for viewing and interpreting radiographic images, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging."
Yes
The device description explicitly states "EzDent-i v3.4 is a device that provides various features... EzDent-i is a patient & image management software specifically for digital dental radiography." While it interfaces with hardware for image acquisition, the device itself is described as software for managing and processing these images.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- EzDent-i's Function: EzDent-i is described as dental imaging software that processes and displays radiographic images (X-rays, CT scans, etc.) of the maxillofacial region. It works with images acquired from imaging equipment, not from specimens taken from the body.
- Intended Use: The intended use clearly states it's for viewing and interpreting radiographic images for diagnostic tools in maxillofacial imaging.
The software's function is focused on processing and managing medical images obtained through non-invasive imaging modalities, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
EzDent-i v3.4 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) but the EzDent-i itself does not view, transfer or process 3D radiographs. None of the changes to the predicate software are related to the 3D functions.
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.
The software level of concern is Moderate.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
panorama, cephalometric, and intra-oral imaging equipment.
CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images
intra-oral camera images.
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals such as radiologist and dentist.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
February 17, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE CA 92612
Re: K223820
Trade/Device Name: EzDent-i / E2 / Prora View/ Smart M Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 15, 2022 Received: December 21, 2022
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. 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
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems 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
2
Indications for Use
510(k) Number (if known)
K223820
Device Name EzDent-i /E2 /Prora View/ Smart M Viewer
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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 (K223820)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 1/10/2023
2. Applicant / Submitter
Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Young Seok Kim Email: eddie.kim@ewoosoft.com
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
4. Subject Device:
- Trade/Device Name: EzDent-i / E2 / Prora View / Smart M Viewer
- Version #: v3.4 ●
- 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
- Version #: v.3.3
- 510k Number: K222145 ●
- Regulation Number: 21 CFR 892.2050 ●
- Regulation Name: Medical Image Management and Processing System ●
4
- Regulatory Class: Class II
- Product Code: LLZ ●
6. Device Description:
EzDent-i v3.4 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) but the EzDent-i itself does not view, transfer or process 3D radiographs. None of the changes to the predicate software are related to the 3D functions.
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.
The software level of concern is Moderate.
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
| Modified Device | Unmodified Device | |
|---|---|---|
| Device name | EzDent-i v3.4 | EzDent-i v3.3 |
| 510K number | K223820 | K222145 |
| Manufacturer | Ewoosoft | Ewoosoft |
| 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. | ||
| 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. | ||
| 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. | ||
| Technology/Principle | ||
| 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 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. | ||
| 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 | ||
| images by interfacing with X-ray capture | ||
| software. | 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 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. | ||
| 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 | ||
| images by interfacing with X-ray capture | ||
| software. | ||
| Platform | IBM-compatible PC or PC network | IBM-compatible PC or PC network |
| Operating System | Windows 10, 11 | Windows 10, 11 |
| User Interface | Mouse, Keyboard | Mouse, Keyboard |
| Image Input Sources | Images can be scanned, loaded from digital | |
| cameras or card readers, or imported from | ||
| a radiographic imaging device | Images can be scanned, loaded from | |
| digital cameras or card readers, or | ||
| imported from a radiographic imaging | ||
| device | ||
| 32 bit / 64 bit | 32 / 64 bit | 32 / 64 bit |
| Image format | DICOM | DICOM |
| Patient Database | ||
| Compatibility | SQL | SQL |
| Includes Image | ||
| Measurement tools | Linear distance, angle | Linear distance, angle |
| Image viewing | Full, side by side, gallery, thumbnail | Full, side by side, gallery, thumbnail |
| Image manipulation | Brightness, contrast, sharpness, inverse, | |
| film view, rotate, zooming, whitening | Brightness, contrast, sharpness, inverse, | |
| film view, rotate, zooming, whitening | ||
| nerve canal tracing, memo | nerve canal tracing, memo | |
| Implant module | Generic implant libraries | Generic implant libraries |
| 3D imaging | Includes interface to 3D imaging software, | Includes interface to 3D imaging software, |
| capability | Ez3D-i. EzDent-i imaging software does | Ez3D-i. EzDent-i imaging software does |
| not view, transfer or process 3D | not view, transfer or process 3D | |
| radiographs. | radiographs. | |
| Image annotation | Text, paint, ellipse, pointer, select, draw, | Text, paint, ellipse, pointer, select, draw, |
| magnify, line, rectangle, polygon, ruler, | magnify, line, rectangle, polygon, ruler, | |
| protractor, smile library, smudge, brush, | protractor, smile library, smudge, brush, | |
| redeye reduction, select region, copy / | redeye reduction, select region, copy / | |
| paste | paste |
8. Substantial Equivalence:
6
EzDent-i v3.4 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.
The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation.
The modifications are adding [Image Share] and [IO sensor image Preview] functions, upgrading the setting tab and the header & footer setting, also supporting image acquisition from PSP scanner. A brief description of the changes from the predicate are as below.
- Setting tab upgrade .
- Dose unit setting can be set separately for extraoral and intraoral x-ray system. -
- Premium skin theme has been added. -
- [Server Control Panel] button has been added. -
- Crown color feature has been added. -
- DICOM tag add/edit/delete feature has been added. -
- Acquisition tab upgrade ● Acquisition tab supports PSP scanner images.
- Patient tab upgrade [Image Share] function has been added to patient tab.
- . Report tab upgrade Additional Header/footer setting features
- Viewer tab upgrade ● IO Sensor filtering preview function on the Viewer tab has been revised.
These differences are not significant since they are additional features for user convenience and do not affect the device safety or effectiveness. Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate device.
7
9. Technological Characteristics:
EzDent-i v3.4 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.
10. Performance Data:
SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
11. Conclusion:
The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The new device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.