(7 days)
Not Found
No
The summary describes standard image processing and visualization tools for dental imaging, with no mention of AI, ML, or related concepts.
No.
The software is for diagnostic purposes, aiding in treatment planning and patient communication, but it does not directly apply or administer therapy.
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." It also mentions "useful tool for diagnosis and analysis" in the device description.
Yes
The device description explicitly states "Ez3D-i is 3D viewing software" and lists various software functions for processing and analyzing dental images. There is no mention of accompanying hardware components included with the device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The intended use and device description clearly state that Ez3D-i is for processing and viewing radiographic images of the maxillofacial region, which are generated externally by imaging equipment.
- The device description focuses on image processing, visualization, and analysis of existing medical images. It does not involve the analysis of biological samples.
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
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.
Ez3D-i is a useful tool for diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP ●
- Versatile 3D image viewing via MPR Rotating, Curve mode
- "Sculpt" for deleting unnecessary parts to view only the region of interest.
- Implant Simulation for efficient treatment planning and effective patient consultation ●
- Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- . "Bone Density" test to measure bone density around the site of an implant(s)
- Various utilities such as Measurement. Annotation. Gallery, and Report
- . 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- . Provides the Axial View of TMJ, the Condyle / Fossa images in 3D and the Section images, and supports functions to separate the Condyle / Fossa and display the bone density.
Mentions image processing
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant dental radiology images.
DICOM images from 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.
The device is for Prescription Use.
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)
Verification, validation and testing activities 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
EWOO SOFT Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt STE 417 IRVINE CA 92620
Re: K163539 Trade/Device Name: Ez3D-i / E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 9, 2016 Received: December 16, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163539
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: 12/09/2016
2. 510k Applicant / Submitter
EWOOSOFT Co., Ltd.
801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do , 18449 , Republic of Korea Tel : +82-31-8015-6172 Fax : +82-31-8015-6196
Contact Person: Young Seok Kim Email: ys.kim@ewoosoft.com
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt STE 417 Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
Ez3D-i / E3
5. Common Name:
Dental Imaging Software
6. Classification:
System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
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7. 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.
Ez3D-i is a useful tool for diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP ●
- Versatile 3D image viewing via MPR Rotating, Curve mode
- "Sculpt" for deleting unnecessary parts to view only the region of interest.
- Implant Simulation for efficient treatment planning and effective patient consultation ●
- Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- . "Bone Density" test to measure bone density around the site of an implant(s)
- Various utilities such as Measurement. Annotation. Gallery, and Report
- . 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- . Provides the Axial View of TMJ, the Condyle / Fossa images in 3D and the Section images, and supports functions to separate the Condyle / Fossa and display the bone density.
8. 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.
9. Predicate Device:
Ez3D-i /E3 (K161246) by EWOO SOFT Co., Ltd.
10. Substantial Equivalence:
Ez3D-i described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K161246).
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 USB Model, Quick Settings, Skin Theme, Implant Guide, Dual monitor and 3D Object Manager functions.
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.
11. 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.
12. Performance Data:
Verification, validation and testing activities 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.
13. Conclusion:
The new device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the non-clinical tests demonstrated that the device is substantially equivalent to the predicate device.