(28 days)
Not Found
No
The document describes standard image processing and visualization tools for dental imaging, with no mention of AI or ML algorithms.
No.
This device is diagnostic imaging software, not a therapeutic device. It is used for viewing and analyzing medical images to aid in diagnosis and treatment planning, but it does not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging."
Yes
The device description explicitly states "Ez3D-i v5.5 is 3D viewing software for dental CT images in DICOM format" and the intended use describes it as "dental imaging software". There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that Ez3D-i is dental imaging software used to view and interpret radiographic images (CT, panorama, cephalometric, intraoral). It processes and visualizes images obtained from imaging equipment, not biological samples.
- Intended Use: The intended use is for providing diagnostic tools for maxillofacial radiographic imaging, which is based on interpreting images, not analyzing biological specimens.
Therefore, Ez3D-i falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ez3D-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.
Ez3D-i 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.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ
Device Description
Ez3D-i v5.5 is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc. for the benefit of effective doctor and patient communication and precise treatment planning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, panorama, cephalometric and intraoral imaging equipment
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
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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.)
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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.
Not Found
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).
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Image /page/0/Picture/0 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.
September 11, 2023
Ewoosoft Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE, CA 92612
Re: K231757
Trade/Device Name: Ez3D-i /E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH
Dear Priscilla Chung:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 14th, 2023. Specifically, FDA is updating this SE Letter's incorrect product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lu Jiang, OHT8: Office of Radiological Health, 240-402-5779, lu.jiang@fda.hhs.gov.
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
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July 14, 2023
Image /page/1/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Ewoosoft Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE, CA 92612
Re: K231757
Trade/Device Name: Ez3D-i /E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 12, 2023 Received: June 16, 2023
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 (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
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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 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 (OS) 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
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Indications for Use
510(k) Number (if known) K231757
Device Name Ez3D-i /E3
Indications for Use (Describe)
Ez3D-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.
Ez3D-i 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 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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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 6/12/2023
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 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
4. Subject Device:
- . Trade/Device Name: Ez3D-i /E3
- Version #: v5.5 ●
- 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: Ez3D-i /E3 ●
- Version #: v5.4
- 510(k) number: K222069
- Regulation number 21 CFR 892.2050 ●
- Regulation name: Picture Archiving and Communications System
- Regulatory Class: Class II
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- Classification Product Code: LLZ .
6. Device Description:
Ez3D-i v5.5 is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc. for the benefit of effective doctor and patient communication and precise treatment planning.
7. Indication for use:
Ez3D-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.
Ez3D-i 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.
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8. Substantial Equivalence:
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Ez3D-i v5.5(E3) | Ez3D-i v5.4(E3) |
| 510K number | - | K222069 |
| Manufacturer | Ewoosoft | Ewoosoft |
| Indications for use | Ez3D-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. |
Ez3D-i 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 | Ez3D-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.
Ez3D-i 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 |
| Platform | IBM-compatible PC or PC network | IBM-compatible PC or PC network |
| Operating System | Microsoft Window 10 or higher | Microsoft Window 10 or higher |
| 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 | 64 bit | 64 bit |
| Image format | DICOM | DICOM |
| Image Measurement
Tools | Length, Multi Length, Angle, Multi Angle,
Circle, ROI/Area, Volume, Profile | Length, Multi Length, Angle, ROI/Area,
Volume, Profile |
| Image viewing | Full, side by side, gallery, thumbnail | Full, side by side, gallery, thumbnail |
| Image manipulation | Grayscale, invert, emboss, brightness,
contrast, gamma, sharpen, median,
despeckle, hue, saturation, equalize, flip,
mirror, masking, rotate, magnify, annotation,
cephalometric tracing, ceph growth
projections, implant simulations | Grayscale, invert, emboss, brightness,
contrast, gamma, sharpen, median,
despeckle, hue, saturation, equalize, flip,
mirror, masking, rotate, magnify,
annotation, cephalometric tracing, ceph
growth projections, implant simulations |
| 3D imaging
capability | Ez3D-i can view, transfer and process 3D
radiographs. Furthermore, it supports Smart
Click, Smart Clipping, Implant Simulation
and Canal Draw. | Ez3D-i can view, transfer and process 3D
radiographs. Furthermore, it supports Smart
Click, Smart Clipping, Implant Simulation
and Canal Draw. |
| 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, rectangle, polygon, ruler,
protractor, smile library, smudge, brush,
redeye reduction, select region, copy / paste |
8.2. Substantial Equivalence Discussion
Ez3D-i v5.5 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K211791, Ez3D-i /E3).
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The subject device and the predicate devices 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, 3D image construction, image edit, measurements and manipulation.
The modifications are changes in PC system requirement information, upgrades on Main Menu (size adjustment for 3D photo and reorientation function), Settings Dialog (server control panel button, DICOM tag customization, and acquisition information display option), Open function (search function, additional side panel, and Patient tab in the environment settings), MPR tab (Switch to Focus CT function), TMJ tab (Draw Curve function), and CONSULT tab and Report (inserting server images).
These differences 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 test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate devices.
9. Technological Characteristics:
Ez3D-i v5.5 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.
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.