(92 days)
No
The summary describes standard image processing and management features without mentioning AI or ML.
No
The device is described as dental imaging software intended to provide diagnostic tools for viewing and interpreting radiographic images, not for therapeutic purposes.
Yes
The intended use 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 it is "patient & image management software" and details its functions related to acquiring, transferring, editing, displaying, storing, and processing digital medical images. While it interfaces with hardware for image acquisition, the device itself is described as software.
Based on the provided information, EzDent-i is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, 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 with biological samples.
- Intended Use: The intended use clearly states it's for viewing and interpreting radiographic images for diagnostic purposes, not for analyzing biological specimens.
Therefore, EzDent-i falls under the category of medical imaging software, not 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
LLZ
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.
Mentions image processing
EzDent-i v3.5 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
panorama, cephalometric, intra-oral imaging equipment, dental CT, intra-oral camera, X-ray capture software
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)
Reference Device(s)
K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069, K231757, K232255
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 (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 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Sunny Lee Email: sunny.lee@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 (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 ●
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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.
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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. | ||
| 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. | Same | ||
| Regulatory Number | |||
| & Common Name | 21 CFR 892.2050 | ||
| Medical image management and processing system | 21 CFR 892.2050 | ||
| Medical image management and processing system | Same | ||
| Device Class | Class II | Class II | Same |
| Software | |||
| Documentation | |||
| Level | Moderate | Basic | Same |
| 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 device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. | Same |
| 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. | 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 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 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 | Same | ||
| Minimum Server PC | |||
| System | - CPU: Dual-Core Processor | ||
| @ 3.4GHz | - CPU: Dual-Core Processor | ||
| @ 3.4GHz | Equivalent | ||
| - RAM: 4GB | - RAM: 8GB | Updated PC | |
| system | |||
| - Display 1280×1024 | - Display 1280×1024 | requirements are | |
| intended to better | |||
| fit the current PC | |||
| Minimum Client PC | |||
| System | - CPU: Dual-Core Processor | ||
| @ 2.7GHz | - CPU: Dual-Core Processor | ||
| @ 2.7GHz | part market | ||
| situation for | |||
| availability. The | |||
| key requirements | |||
| - RAM: 4GB | - RAM: 4GB | such as CPU are | |
| not changed thus | |||
| - Display 1024×768 | - GPU: Internal or External | ||
| GPU Supporting | |||
| OpenGL2.1 | the modifications | ||
| do not affect | |||
| - Display 1024×768 | substantial | ||
| equivalence to the | |||
| Network | Wired or Wireless Network | Wired or Wireless Network | Same |
| - Wired: 100M ethernet LAN | - Wired: 100M ethernet LAN | ||
| (CAT 5 cable) |
- Wireless: 802.11n | (CAT 5 cable)
- 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
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 | Same |
| 32 bit / 64 bit | 32 / 64 bit | 32 / 64 bit | Same |
| Image format | DICOM | DICOM | Same |
| Patient Database
Compatibility | SQL | SQL | Same |
| Includes Image
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,
inverse, film view, rotate,
zooming, whitening, nerve canal
tracing, memo | Brightness, contrast, sharpness,
inverse, film view, rotate,
zooming, whitening, nerve canal
tracing, memo | Same |
| Implant module | Generic implant libraries | Generic implant libraries | Same |
| 3D imaging
capability | Includes interface to 3D imaging
software, Ez3D-i. EzDent-i
imaging software does not view,
transfer or process 3D
radiographs. | Includes interface to 3D imaging
software, Ez3D-i. EzDent-i
imaging software does not view,
transfer or process 3D
radiographs. | Same |
| | | | |
| Image annotation | Text, paint, ellipse, pointer,
select, draw, magnify, line,
rectangle, polygon, ruler,
protractor, smile library,
smudge, brush, redeye reduction,
select region, copy / paste | Text, paint, ellipse, pointer,
select, draw, magnify, line,
multi-line, rectangle, polygon,
ruler, protractor, smile library,
smudge, brush, redeye reduction,
select region, copy / paste | Equivalent
- [Multi-line]
tool, an upgrade to
existing [Line] tool
is added. - A tool to
directly open
Annotation
Properties dialog
added. The role of
the dialog is
identical to the
annotation settings
on the Settings
dialog of the
unmodified device.
Thus, the
modifications do
not affect
substantial
equivalence to the
predicate device. |
| Distribution of
Installation File for
Upgrade | USB | USB, EzUpdater | Equivalent
Online distribution
of installation files
supported through
EzUpdater.
However, the
installation process
is identical. |
| Customer Support | Manufacturer website, phone
number, and e-mail information
provided. | Manufacturer website, phone
number, and e-mail information
provided. | Same
(with a tool to
access to CS
website) |
| Dose Information
Display | File information | File information, Dose
indicator(if applicable) | Equivalent
Dose indicator is
added in order to
support EzSensor
XHD(K232255).
However, the role
of EzDent-i is not
to calculate the |
| | | | information but to
visualize the
received
information into
dose indicator.
Thus, the key
feature, displaying
the received value,
is identical to the
predicate device
and the
modification does
not affect
substantial
equivalence to the
predicate device. |
| Report Management | Create, open, view, edit, delete | Create, open, view, edit, delete | Same
(with [Delete]
feature added to
thumbnail list) |
| Pre-integrated PMS | Clever | Clever Dent(Previous name:
Clever), Weclever | Equivalent
The list of pre-
integrated PMS is
expanded. The
modification is
only an upgrade of
existing feature
and the
modification does
not affect
substantial
equivalence to the
predicate device |
| Send E-mail | Send e-mail, attachment,
signature, convert report to,
convert image to, patient
information anonymization | Send e-mail, attachment,
compress to zip file, signature,
convert report to, convert image
to, patient information
anonymization | Equivalent
[Compress to .zip
file] feature is
added as an
upgrade to the
attachment. The
modification is not
a newly added
feature but
identical to the
[Compress to .zip
file] feature on the
Export function of |
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10
| the predicate | |
|---|---|
| device. The key | |
| features of Send E- | |
| mail function is | |
| not changed thus, | |
| the modification | |
| does not affect | |
| substantial | |
| equivalence to the | |
| predicate device. | |
EzDent-i v3.5 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 PC system requirement information change, EzUpdater added for online downloads, Customer Support Icon added for user convenience, and some upgrades in Viewer Tab, Patient Management, and E-mail functions. These differences are not significant since they are additional features for user convenience and do not raise the questions of 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.
9. Technological Characteristics:
EzDent-i v3.5 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. Also we have addressed the recommendations in the most recent cybersecurity guidance, "Cybersecurity in Medical Devices Quality System Considerations and Content of Premarket Submissions".
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
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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.