(71 days)
Not Found
No
The document describes standard 3D visualization and analysis tools for dental imaging, with no mention of AI or ML capabilities.
No.
The software is for diagnostic imaging and treatment planning, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is "intended to provide diagnostic tools for maxillofacial radiographic imaging."
Yes
The device is explicitly described as "dental imaging software" and "3D viewing software" that processes DICOM images from various imaging equipment. The description focuses solely on software functionalities and performance studies relate to software verification/validation. There is no mention of accompanying hardware components being part of the device itself.
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.
- Ez3D-i's function: Ez3D-i is software that processes and visualizes medical images (CT, panorama, cephalometric, intraoral) taken from within the body. It provides diagnostic tools based on these images, not on analysis of biological samples.
The software's purpose is to aid in the interpretation of radiographic images for diagnosis and treatment planning, which falls under the category of medical imaging software, not in vitro diagnostics.
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
LLZ
Device Description
Ez3D-i 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
Not Found
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
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)
Not Found
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).
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August 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612
Re: K211791
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 4, 2021 Received: June 10, 2021
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
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) | |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv
(K211791)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 8/9/2021
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. Device Information:
- 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
5. Predicate Device:
- Manufacturer: Ewoosoft Co., Ltd. ●
- Trade/Device name: Ez3D-i /E3
- 510(k) number: K200178
- Regulation number 21 CFR 892.2050 ●
- . Regulation name: Picture Archiving and Communications System
- Regulatory Class: Class II ●
- . Classification Product Code: LLZ
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6. Device Description:
Ez3D-i 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 v5.3(E3) | Ez3D-i v5.2(E3) |
| 510K number | K211791 | K200178 |
| 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 8, 10 | Microsoft Window 7, 8, 10 |
| 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 |
| 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 |
Ez3D-i described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K200178, Ez3D-i /E3).
The subject device and the predicate devices are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture
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archiving and communication format, image format, image processing features, windowing, 3D image construction, image edit, measurements and manipulation.
The differences are that the subject device has additional features such as changes in PC system requirement information, login/logout function, the location of the User Account Management to Server Web Console EzServer, license plan options setting, export icon function, show/hide patient information icon function, adding and deleting VR coloring graph function, MPR interval function, and export to DICOM function. 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 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.