← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K183676 # DentiqAir (K183676) _3D Industrial Imaging Co., Ltd. · LLZ · Dec 19, 2019 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K183676 ## Device Facts - **Applicant:** 3D Industrial Imaging Co., Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Dec 19, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. ## Device Story DentiqAir is a software application for visualizing and segmenting 3D volume data (CT/CBCT) and optical impressions of the oral-maxillofacial and ENT regions. Used by dental professionals in clinical settings, it transforms raw scan data into 3D visualizations and segmentations (e.g., airway, mandible, fossa) using a watershed algorithm. The software provides tools for length and angle measurements, volume clipping, and data manipulation (zoom, pan, brightness/contrast). Planning data can be exported for use in CAD or rapid prototyping systems. The device aids clinicians in evaluating treatment options; it does not perform automated diagnosis. Benefits include improved visualization of anatomical structures for treatment planning. ## Clinical Evidence No clinical data performed. Bench testing only. Accuracy validated using phantom CT datasets comparing measured values (length, angle, HU, volume) against true values. P/F criteria for length, angle, and HU was <2% average/max absolute difference; volume accuracy was validated against true values and compared to Dolphin Imaging. ## Technological Characteristics Pure software device; runs on Windows 7/8/10 (64-bit). Requires Intel i3 Dual Core, 2GB RAM, 2GB HDD, DirectX 10.1 compatible graphics. Uses ray-casting for volume rendering and watershed (graph-cut) algorithm for segmentation. Connectivity: DICOM import, STL import, proprietary 3DII project format export. C# and C++ implementation. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - SICAT Function ([K133320](/device/K133320.md)) ## Reference Devices - Dolphin Imaging ([K110430](/device/K110430.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. December 19, 2019 3D Industrial Imaging Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-Gu, 08301 REPUBLIC OF KOREA ## Re: K183676 Trade/Device Name: DentiqAir Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 8, 2019 Received: November 13, 2019 ## Dear Sanglok Lee: 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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. 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name Indications for Use (Describe) 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) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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." {4}------------------------------------------------ Bldg.138, Rm.413, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826) ### 510(k) Summary - Traditional 510(K) ### The assigned 510(k) Number: K183676 ### 01. Date of Submission: 2019.11.08 ### 02. Applicant / Submitter 3D Industrial Imaging Co., Ltd. Bldg.138, Rm.413, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826) Tel. +82-70-8766-9192 #### 03. Submission Correspondent Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org ### 04. Proposed Device Identification #### Device Identification and Regulatory information Proprietary Name: DentiqAir Common/Usual Name: Radiological Visualization Software for Diagnosis and Treatment Planning Classification Name: System, Image Processing, Radiological Regulation Description: Picture archiving and communications system Product Code: LLZ Regulation Number: 21 CFR 892.2050 Classification Class: Class II Product #### Indications for use: DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. #### 05. Predicate Device Identification - Reference predicate device 510(k) Number: K110430 Device Name: Dolphin Imaging Manufacturer: PATTERSON DENTAL SUPPLY, INC - Primary predicate device 510(k) Number: K133320 Device Name: SICAT Function Manufacturer: SICAT GmbH & Co, KG #### 06. Device Description DentiqAir is a pure software device applied for the visualization of imaging information of the ear-nose-throat (ENT) region and oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems. The medical professionals' input information and planning data may be exported from Dentiq Air to be used for CAD or Rapid Prototyping Systems. {5}------------------------------------------------ Bldg.138, Rm.413, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826) ## 07. Technological Characteristics: DentiqAir requires Windows 7 64 bit OS or above. To ensure proper operation, we recommend installing the subject device on a system with the following specifications or higher. | Item | Specifications | |---------------|-------------------------------------------------------| | Processor | Intel i3 Dual Core | | System Memory | 2 GB | | HDD | 2 GB free hard disk space | | Graphics Card | Graphics cards compatible with DirectX 10.1 or Higher | | Display | 1600 x 900 or Higher | Table 1. Minimum PC Specification Requirements for DentiqAir. ## 08. Substantially Equivalent DentiqAir has the same intended uses, principle of operation and similar technical characteristics and functionality as predicate devices. | Feature name | Subject Device | Reference predicate Device | Primary
predicate
Device | SE
Decision | |-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | DentiqAir | Dolphin Imaging | SICAT
Function | - | | Common/Usual
Name | Radiological Visualization
Software for Diagnosis
and Treatment Planning | Not available | Radiological
Visualization
Software for
Diagnosis and
Treatment
Planning | - | | 510K number | - | K110430 | K133320 | - | | Classification | Regulation number: 21
CFR 892.2050
Product code: LLZ | Regulation number: 21 CFR
892.2050
Product code: LLZ | Regulation
number: 21
CFR
892.2050
Product code:
LLZ | Equivalent
with
primary
and
reference
device | | Manufacturer | 3D Industrial Imaging Co.
Ltd | PATTERSON DENTAL
SUPPLY, INC. | SICAT
GmbH & Co,
KG | - | | Supported
anatomic areas | Maxilla, Mandible | Maxilla, Mandible | Maxilla,
Mandible | Equivalent
with
primary
and
reference
device | | Indications for Use | | | | | | Indications for
Use | DentiqAir: DentiqAir is a software application for the visualization and
segmentation of imaging information of the oral-maxillofacial region. The | | | | | | imaging data originates from medical scanners such as CT or CBCT scanners.
The dental professionals' planning data may be exported from DentiqAir and
used as input data for CAD or Rapid Prototyping Systems.
Intended Use Statement of 510(k) Summary K110430: “Dolphin Imaging
software is designed for use by specialized dental practices for capturing,
storing and presenting patient images and assisting in treatment planning and
case diagnosis. Results produced by the software's diagnostic and treatment
planning tools are dependent on the interpretation of trained and licensed
practitioners.” | | | primary
device | | | Indications for Use Statement of 510(k) Summary K133320: SICAT Function
is a software application for the visualization and segmentation of imaging
information of the oral-maxillofacial region. The imaging data originates from
medical scanners such as CT or CBCT scanners. It is also used as a software
system to aid qualified dental professionals with the evaluation of dental
treatment options. The dental professionals' planning data may be exported
from SICAT Function and used as input data for CAD or Rapid Prototyping
Systems | | | | | contraindicatio
ns | none | unknown | none | Equivalent
with
primary
device | | | Medical Data Viewing | | | | | Data types
visualized | 3D volume data, optical
impressions | 3D volume data, 2D
radiological x-ray data,
images and photographs | 3D volume
data, optical
impressions,
jaw motion
tracking data | Equivalent
with
primary
and
reference
device | | Imaging data
visualization
region | ENT region including the
oral-maxillofacial region | ENT region including the
oral-maxillofacial region | Oral-
maxillofacial
region | Equivalent
with
primary
and
reference
device | | Viewing Modes | | | | | | Orthogonal
slices | Axial, coronal, sagittal | Axial, coronal, sagittal | Axial,
coronal,
sagittal | Equivalent
with
primary
and
reference
device | | Special Dental
View:
Panoramic | No | Yes | Panoramic
view (ray
sum) | DentiqAir
does not
support | | View | | | | View | | Special dental view:
Cephalometric View | No | Yes | panoramic curve.
Panoramic curve can be
manually adjusted. | Panoramic View.
Equivalent with
primary device | | Special dental views:
TSA and LSA | Single transversal slices
are generated. | Single transversal slices are
generated. | Transversal slice (TSA)
and longitudinal
slice (LSA), both with
respect to panoramic
curve. | Equivalent with
reference device | | 3D volume rendering | Yes, volume rendering
using a standard and well
established ray-casting
algorithm with integration
along rays, and volume
rendering utilizing
standard shader based
slicing algorithms
available on typical
consumer graphics
hardware. | Yes | Yes | Equivalent with
primary and
reference device | | 3D surface rendering of
volume data | Yes, using a standard and
Well established front-to-
back ray-casting algorithm
with an iso-surface
threshold. | Yes | No | Equivalent with
reference device | | Volume Data Navigation and Manipulation | | | | | | View manipulating
tools | Zoom, Pan, Change of
orientation | Yes | Zoom, Pan, Change of
orientation | Equivalent with
primary and
reference device | | Color manipulating
tools | Brightness, Contrast | Yes | Brightness, Contrast | Equivalent with
primary and
reference device | | Scrolling
through
slices | For all slices(without
panoramic slicing
window) | Yes | For all slices
(including
panoramic
slicing
window) | Equivalent
with
primary
and
reference
device
but
DentiqAir
does not
support
panoramic
slicing
window | | 3D volume
Clipping | Yes, Features and
Algorithms identical to
SICAT Function | Yes | Yes | Equivalent
with
primary
and
reference
device | | Measurements | | | | | | Length
measurement | Yes | Yes | Yes | Equivalent
with
primary
and
reference
device | | Area
measurement | No | Yes | No | Equivalent
with
primary
device | | Angle
measurement | Yes | Yes | Yes | Equivalent
with
primary
and
reference
device | | Overall Length
Measurement
Accuracy | 100 μm | Unknown | 100 μm | Equivalent
with
primary
device | | Overall
Angular
Measurement
Accuracy | 1 degree | Unknown | 1 degree | Equivalent
with
primary
device | | Segmentation of Anatomical Structures | | | | | | Segmentation
of
anatomical
structures | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut
algorithm) | Yes
Segmentation algorithm is
unknown | Yes, using a
segmentation
wizard.
Algorithm:
Water Shed (a
type of graph-
cut algorithm) | Equivalent
with
primary
and
reference
device | | Airway
Segmentation | Airway Segmentation of
the Airway using the
segmentation wizard. | Yes
Segmentation algorithm is
unknown | No | Equivalent
with
reference
device | | Segmentation
of
mandible and
fossa | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut
algorithm) | No | Yes, using a
segmentation
wizard.
Algorithm:
Water Shed (a
type of graph-
cut algorithm) | Equivalent
with
primary
device | | Mesh texturing
of the
segmented
Airway | The Airway is texturized
by a standard algorithm.
Or The Airway is
texturized by the cross-
sectional | Yes | No | Equivalent
with
reference
device | | Optical Impression Data Visualization | | | | | | Optical
impression
(maxilla,
mandible, or a
part thereof) | Optical impression
(maxilla, mandible, or a
part thereof)
Polygonal mesh in 3D
view, cut
through polygonal mesh
(contour) in slice view | No | Optical
impression
(maxilla,
mandible, or a
part thereof)
Polygonal
mesh in 3D
view and
panorama
view, cut
through
polygonal
mesh
(contour) in
slice view | Equivalent
with
primary
device | | Optical
impression
name | No | No | A list view in
a dedicated
toolbar
contains the
names
of all loaded
optical | Equivalent
with
reference
device | | | | | impressions. | | | Show/Hide an optical impression | Yes
Visibility applies to all views simultaneously. | No | Yes
Visibility applies to all views simultaneously. | Equivalent with primary device | | Optical Impression Data Manipulation | | | | | | Registration of surface data (from optical impressions) to volume data | Semi-automatic, using user specified reference points. | No | Semi-automatic, using user specified reference points. | Equivalent with primary device | | Fine tuning the accuracy of the registration | Yes, Restart of the registration with a different set of reference points and Move/Rotate in MPR cross-section image. (Axial/Sagittal/Coronal) | No | Restart of the registration with a different set of reference points. | Equivalent with primary device | | Delete | Yes | No | Yes | Equivalent with primary device | | I/O | | | | | | Volume Data Import | DICOM | DICOM | DICOM | Equivalent with primary and reference device | | Optical surface data/optical impression import | Standard STL format | No | Standard STL format and proprietary SSI or SIXD container format. | DentiqAir support only STL Format | | Data Import/Export Data Compression | A “Project” consisting of planning data (including segmentation information), volume data, and optical surface data may be exported and imported in a 3DII proprietary format. | No | A “study” consisting of planning data (including segmentation information), volume data, jaw motion | Equivalent with primary device | | | | | data and
optical
surface data
may be
exported and
imported in a
SICAT
proprietary
format.
Lossless ZIP
compression | | | Export of data
for CAD and
rapid proto-
typing | Yes | No | Yes | Equivalent
with
primary
device | | Misc. functions | | | | | | Soft tissue
simulation with
photo mapping | No | Yes | No | Equivalent
with
primary
device | | Cross sections
in
Multiple Planar
View (MPV) | No | Yes | No | Equivalent
with
primary
device | | Volume
stitching:
Combine two
separate
volumes
into one | No | Yes | No | Equivalent
with
primary
device | | 2D facial photo
wrap onto
volume | No… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K183676](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K183676) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com