Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The "Mentions AI, DNN, or ML" section explicitly states the use of deep-learning algorithms for various segmentation and detection tasks.

Therapeutic

No
The device is a software for image analysis and quantification in support of diagnosis and follow-up, not a treatment.

Diagnostic

Yes

The intended use explicitly states that the software supports "the physician quantitatively in the diagnosis" and is "intended for use as diagnostic patient imaging". It also lists various characterizations and measurements for nodules and CAC analysis, which are used in diagnosis.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "The AVIEW is a software product which can be installed on a PC." and the intended use and device description focus solely on software functionalities for image processing, analysis, and reporting of CT data. There is no mention of accompanying hardware components that are part of the medical device itself.

IVD (In Vitro Diagnostic)

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 AVIEW software processes and analyzes medical images (CT scans) taken of the body, not from the body. It provides quantitative information and analysis based on the visual data within the images.
Intended Use: The intended use clearly states that it provides CT values for pulmonary tissue from CT thoracic and cardiac datasets and supports physicians in the diagnosis and follow-up evaluation of these images. This is image analysis, not laboratory testing of biological samples.

While the software provides quantitative data and aids in diagnosis, the source of the data is medical imaging, not in vitro testing of biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked "Not Found," indicating no such text in the provided information.

Overview

Intended Use / Indications for Use

A VIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software could be used to support the physician quantitatively in the diagnosis, follow up evaluation of CT lung tissue images by providing image segmentation of sub-structures in lung, lobe, airways and cardiac, registration and expiration which could analyze quantitative information such as air trapped index, and inspiration/ expiration ratio. And also, volumetric and structure analysis, density evaluation and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise and as cloud environment as well to allow users to connect by various environment such as mobile devices and chrome browser. Characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major axis), estimated effective diameter from the volume of the nodule, volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric measures(Solid major; length of the longest diameter measured in 3D for solid portion of the nodule, Solid 2nd Major: The longest diameter of the solid part, measured in sections perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with findings). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA certified Mevis CAD (Computer aided detection) (K043617). It also provides CAC analysis by segmentation of four main artery (right coronary artery, left main coronary, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score and mass score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.

Product codes (comma separated list FDA assigned to the subject device)

LLZ, JAK

Device Description

The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools. And is intended for use as diagnostic patient imaging which is intended for the review and analysis of CT scanning. Provides following features as semi-automatic nodule management, maximal plane measure, 3D measures and columetric measures, automatic nodule detection by integration with 3rd party CAD. Also provides Brocks model which calculated the malignancy score based on numerical or Boolean inputs. Follow up support with automated nodule matching and automatically categorize Lung-RADS score which is a quality assurance tool designed to standardize lung cancer screening CT reporting and management recommendations that is based on type, size, size change and other findings that is reported. It also automatically analyzes coronary artery calcification which support user to detect cardiovascular disease in early stage and reduce the burden of medical.

Fully automatic pre-processing .
Fully automatic lung/lobe segmentation using deep-learning algorithms. •
. Fully automatic airway segmentation using deep-learning algorithms.
Fully automatic INSP/EXP registration (non-rigid elastic) algorithm. ●
COPD analysis ●
. LAA analysis (LAA-950HU for INSP, LAA-856HU for EXP)
. LAA size analysis (D-Slope)
The world-first true 3D analysis of LAA cluster sizes. •
. Precise airway wall thickness measurement
. Robust measurement using IBHB (Integral-Based Half-BAND) method.
Precise AWT-Pi10 calculation from 10 samples per each branch .
Air-trapping analysis using INSP/EXP registration
. PRM analysis using INSP/EXP registration (Not available in US)
. Unique pulmonary vessel analysis method (Lobar-pealing method)
Easy and comprehensive UI ●
Multiple database management
Comprehensive dynamic bull's eye chart and tables. .
Web-based access to analysis results, including 3D rendering (Thin-client technology) .
. PDF report generation
Interoperability ●
DICOM 3.0 COMPLIANT: C-STORE, C-FIND, C-MOVE and C-ECHO .
Resulting images and report can be transferred to PACS through DICOM connection
Thin client service
Connected from anywhere, anyplace, anytime. .
. Supports mobile view through various mobile devices served by iOS and Android.
. Compatible with Chrome browser
Research-support ●
1000+ feature values are exporting for radiomics research. ●
. All the segmentation masks are stored in open format (such as Analyze or NifTi)
Easy processing management ●
Rule-based automatic processing server (APS) ●
. Scaling
Nodule Management ●
Adding nodule by segmentation or by lines. ●
Semi-automatic nodule measurement (segmentation)
. Maximal plane measure, 3D measure and volumetric measure.
. Automatic large vessel removal.
. Provides various features calculated per each nodule.
. Fully supporting Lung-RADS workflow: US Lung-RADS and KR Lung-RADS.
. Nodule malignancy score (PANCAN model calculation.)
. Importing from CAD results.
Follow-up ●
Automatic retrieving the past data .
Follow-up support with nodule matching and comparison
. Automatic calculation of VDT (volume doubling time)
Lungs, Lobes and Airway segmentation
Better segmentation of lungs, lobes and airway based on deep-learning algorithms.
· Automatic nodule detection (CADe)
Seamless integration with Mevis Visia (FDA 510(k) Cleared) .
· Coronary Artery Calcification
Extracts calcium coronary artery and provide Agatston Score, Volume Score and Mass score. .
Automatically segments calcium area of coronary artery based on deep learning
. Segments and provides overlay of four main artery (right coronary artery, left main coronary, left anteriordescending, and left circumflex artery) and myocardium
. Provides CAC risk based on age and gender.
· Report
PDF report generation •
. It saves or sends the pdf report and captured images in DICOM files.
. Reports are generated using the results of all nodules detected so far (Lung RADS)
. Save Result
It saves the results in internal format ●

Mentions image processing

Yes

Mentions AI, DNN, or ML

Mentions deep-learning algorithms for fully automatic lung/lobe segmentation, fully automatic airway segmentation, and automatic segmentation of calcium area of coronary artery.

Input Imaging Modality

CT thoracic and cardiac datasets

Anatomical Site

Pulmonary tissue (lungs, lobes, airways), Heart (cardiac), Coronary artery

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician, on premise and as cloud environment

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)

Nonclinical Performance Testing

This Medical device is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing

Software Verification and Validation

Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified device passed all of the tests based on pre-determined Pass/Fail criteria.

Unit Test
Conducting Unit Test using Google C++ Unit Test Framework on major software components identified by software development team. List of Unit Test includes Functional test condition for software component unit, Performance test condition, and part of algorithm analysis for image processing algorithm.
System Test -
In accordance with the document 'integration Test Cases' discussed in advanced by software development team and test team, test is conducted by installing software to hardware with recommended system specification. Despite Test case recognized in advance was not in existence. New software error discovered by 'Exploratory Test' conducted by test team will be registered and managed as new test case after discussion between development team and test team.
Discovered software error will be classified into 3 categories as severity and managed.
Major defects, which are impacting the product's intended use and no workaround is available.
Moderate defects, which are typically related to user-interface or general quality of product, while workaround is available.
Minor defects, which aren't impacting the product's intended use. Not significant.
Success standard of System Test is not finding 'Major', 'Moderate' defect.
Performance Test
· Auto Lung & Lobe Segmentation
Airway Segmentation .
Nodule Matching Experiment Using Lung Registration .
Validation on DVF Size Optimization with Sub-sampling ●
Semi-automatic Nodule Segmentation
Brock Model (ask PANCAN) Calculation .
VDT Calculation .
. Lung RADS Calculation
Validation LAA Analysis ●
Validation LAA Size Analysis ●
Size analysis algorithm of LAA clusters ●
Lung Registration
Reliability Test for Airway wall Measurement
CAC Performance ●
Air Trapping Analysis .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K171199

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.

K141069, K193220, K183268, K990426

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

Regulation Number and Section

§ 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).

Summary

0

September 17, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center, while the FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Coreline Soft Co., Ltd Hye Yi Park Deputy General Manager/Strategic Business Dept. 4, 5F (Yeonnam-dong) 49, World Cup buk-ro-6-gil, Mapo-gu, Seoul, Republic of Korea

Re: K200714

Trade/Device Name: AVIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK

Dear Hye Yi Park:

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 August 26, 2020. Specifically, FDA is updating this SE Letter for a typographical error in the trade name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia T. Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6641, thalia.mills@fda.hhs.gov.

Sincerely,

Michael D. O'Hara 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

1

August 26, 2020

Image /page/1/Picture/1 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 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.

Coreline Soft Co., Ltd % Hyeyi Park Deputy General Manager/Strategic Business Dept. 4, 5F (Yeonnam-dong) 49 World Cup buk-ro-6-gil Mapo-gu, Seoul 03991 REPUBLIC OF KOREA

Re: K200714

Trade/Device Name: AVIEW 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: July 17, 2020 Received: July 20, 2020

Dear Hyeyi Park:

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 mav, 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

2

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,

Michael D. O'Hara 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

3

Indications for Use

510(k) Number (if known) K200714

Device Name AVIEW

Indications for Use (Describe)

A VIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software could be used to support the physician quantitatively in the diagnosis, follow up evaluation of CT lung tissue images by providing image segmentation of sub-structures in lung, lobe, airways and cardiac, registration and expiration which could analyze quantitative information such as air trapped index, and inspiration/ expiration ratio. And also, volumetric and structure analysis, density evaluation and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise and as cloud environment as well to allow users to connect by various environment such as mobile devices and chrome browser. Characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major axis), estimated effective diameter from the volume of the nodule, volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric measures(Solid major; length of the longest diameter measured in 3D for solid portion of the nodule, Solid 2nd Major: The longest diameter of the solid part, measured in sections perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with findings). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA certified Mevis CAD (Computer aided detection) (K043617). It also provides CAC analysis by segmentation of four main artery (right coronary artery, left main coronary, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score and mass score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.

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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4

K200714

510(k) Summary

SUBMITTER 1

Coreline Soft Co., Ltd. 4,5F (Yeonnam-dong), 49 World Cup buk-ro 6-gil, Mapo-gu, Seoul, 03991, Republic of Korea.

Phone: 82.2.517.7321 Fax: 82.2.571.7324

Contact Person: hyeyi. Park Date Prepared: 03.13.2020

2 DEVICE

Name of Device: AVIEW Common or Usual Name: Image Processing Software Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ, JAK

PREDICATE DEVICE 3

AVIEW by Coraline Soft Co., Ltd. (K171199)

Name of Device: AVIEW Common or Usual Name: Image Processing Software Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ

This predicate has not been subject to a design-related recall

REFERENCE DEVICE 4

Imbio CT Lung Density Analysis Software by Imbio LLC (K141069) Name of Device: Imbio CT Lung Density Analysis Software Common or Usual Name: Software Accessory to a Computed Tomography Device Classification Name: System, X-ray tomography, Computed (21CFR 892.1750) Regulatory Class: II Product Code: JAK

5

AVIEW LCS by Coraline Soft Co., Ltd. (K193220) Name of Device: AVIEW LCS Common or Usual Name: Image Processing Software Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ, JAK

AI-Rad Companion (Cardiovascular) by Siemens Medical Solutions USA, Inc. (K183268) Name of Device: AI-Rad Companion (Cardiovascular) Common or Usual Name: AI-Rad Companion (Cardiovascular) Classification Name: Computed tomography x-ray system (21CFR 892.1750) Regulatory Class: II Product Code: JAK, LLZ

Calcium Scoring by Siemens Medical Solutions, Inc. (K990426) Name of Device: Calcium Scoring Common or Usual Name: Calcium Scoring Classification Name: System, X-ray tomography, Computed (21CFR 892.1750) Regulatory Class: II Product Code: JAK

This reference device has not been subject to a design-related recall

5 DEVICEW DESCRIPTION

The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools. And is intended for use as diagnostic patient imaging which is intended for the review and analysis of CT scanning. Provides following features as semi-automatic nodule management, maximal plane measure, 3D measures and columetric measures, automatic nodule detection by integration with 3rd party CAD. Also provides Brocks model which calculated the malignancy score based on numerical or Boolean inputs. Follow up support with automated nodule matching and automatically categorize Lung-RADS score which is a quality assurance tool designed to standardize lung cancer screening CT reporting and management recommendations that is based on type, size, size change and other findings that is reported. It also automatically analyzes coronary artery calcification which support user to detect cardiovascular disease in early stage and reduce the burden of medical.

Fully automatic pre-processing .
- Fully automatic lung/lobe segmentation using deep-learning algorithms. •
- . Fully automatic airway segmentation using deep-learning algorithms.
- Fully automatic INSP/EXP registration (non-rigid elastic) algorithm. ●
COPD analysis ●

6

. LAA analysis (LAA-950HU for INSP, LAA-856HU for EXP)
. LAA size analysis (D-Slope)
- The world-first true 3D analysis of LAA cluster sizes. •
. Precise airway wall thickness measurement
- . Robust measurement using IBHB (Integral-Based Half-BAND) method.
- Precise AWT-Pi10 calculation from 10 samples per each branch .
Air-trapping analysis using INSP/EXP registration
. PRM analysis using INSP/EXP registration (Not available in US)
. Unique pulmonary vessel analysis method (Lobar-pealing method)
Easy and comprehensive UI ●
- Multiple database management
- Comprehensive dynamic bull's eye chart and tables. .
- Web-based access to analysis results, including 3D rendering (Thin-client technology) .
- . PDF report generation
Interoperability ●
- DICOM 3.0 COMPLIANT: C-STORE, C-FIND, C-MOVE and C-ECHO .
- Resulting images and report can be transferred to PACS through DICOM connection
Thin client service
- Connected from anywhere, anyplace, anytime. .
- . Supports mobile view through various mobile devices served by iOS and Android.
- . Compatible with Chrome browser
Research-support ●
- 1000+ feature values are exporting for radiomics research. ●
- . All the segmentation masks are stored in open format (such as Analyze or NifTi)
Easy processing management ●
- Rule-based automatic processing server (APS) ●
  - . Scaling
Nodule Management ●
- Adding nodule by segmentation or by lines. ●
- Semi-automatic nodule measurement (segmentation)
- . Maximal plane measure, 3D measure and volumetric measure.
- . Automatic large vessel removal.
- . Provides various features calculated per each nodule.
- . Fully supporting Lung-RADS workflow: US Lung-RADS and KR Lung-RADS.
- . Nodule malignancy score (PANCAN model calculation.)
- . Importing from CAD results.
Follow-up ●
- Automatic retrieving the past data .
- Follow-up support with nodule matching and comparison
- . Automatic calculation of VDT (volume doubling time)
Lungs, Lobes and Airway segmentation
- Better segmentation of lungs, lobes and airway based on deep-learning algorithms.
· Automatic nodule detection (CADe)
- Seamless integration with Mevis Visia (FDA 510(k) Cleared) .
· Coronary Artery Calcification
- Extracts calcium coronary artery and provide Agatston Score, Volume Score and Mass score. .
- Automatically segments calcium area of coronary artery based on deep learning

7

. Segments and provides overlay of four main artery (right coronary artery, left main coronary, left anteriordescending, and left circumflex artery) and myocardium
. Provides CAC risk based on age and gender.
· Report
- PDF report generation •
- . It saves or sends the pdf report and captured images in DICOM files.
- . Reports are generated using the results of all nodules detected so far (Lung RADS)
. Save Result
- It saves the results in internal format ●

INDICATIONS FOR USE 6

AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software could be used to support the physician quantitatively in the diagnosis. follow up evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in lung, lobe, airways and cardiac, registration of inspiration and expiration which could analyze quantitative information such as air trapped index, and inspiration/expiration ratio. And also, volumetric and structure analysis, density evaluation and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise and as cloud environment as well to allow users to connect by various environment such as mobile devices and chrome browser. Characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major axis), estimated effective diameter from the volume of the nodule, volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU, mass calculated from the CT pixel value), and volumetric measures(Solid major; length of the longest diameter measured in 3D for solid portion of the nodule, Solid 2nd Major: The length of the longest diameter of the solid part, measured in sections perpendicular to the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with findings). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA certified Mevis CAD (Computer aided detection) (K043617). It also provides CAC analysis by segmentation of four main artery (right coronary artery, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH 7 THE PREDICATE DEVICE

AVIEW has the same intended use and the principle of operation and has similar features to the predicate devices. AVIEW (K171199)

There might be slight differences in features and menu, but these differences between the predicate device and the proposed device are not so 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 results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices.

| Characteristic | Subject Device | Primary Predicate
Device | Reference Device | Reference Device | Reference Device | Reference Device | Regulatory
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1750 | 21 CFR 892.2050 | 21 CFR 892.1750 | 21 CFR 892.1750 | | Keyboard | Keyboard | Keyboard | Keyboard | Keyboard | Keyboard |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|---------------------------------------------|-----------------------------------------|----------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------|------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Device Name | AVIEW 2.0 | AVIEW | Imbio CT Lung
Density Analysis
Software | AVIEW LCS | AI-Rad
Companion
(Cardiovascular) | Calcium Scoring | Product Code | LLZ, JAK | LLZ | JAK | LLZ, JAK | JAK | JAK | Image Input
Sources | Images can be scanned,
loaded from card
readers, or imported
from a radiographic
imaging device | Images can be
scanned, loaded
from card readers, or
imported from a
radiographic
imaging device | Images can be scanned,
loaded from card
readers, or imported
from a radiographic
imaging device | Images can be
scanned, loaded from
card readers, or
imported from a
radiographic imaging
device | Images can be
scanned, loaded
from card readers, or
imported from a
radiographic
imaging device | Images can be
scanned, loaded
from card readers, or
imported from a
radiographic imaging device |
| Classification
Name | System, image
Processing Radiological | System, image
Processing
Radiological | Computed Tomography
x-ray system | System, image
Processing
Radiological | Computed
Tomography x-ray
system | Computed
Tomography x-ray
system | Review Panel | Radiology | Radiology | Radiology | Radiology | Radiology | Radiology | Image format | DICOM | DICOM | DICOM | DICOM | DICOM | DICOM |
| 510k Number | - | K171199 | K141069 | K193220 | K183268 | K990426 | Image
Measurement
Tools | Ruler (line and 3D),
Tapeline (curve, poly
and3D), Angle (3-point,
4point, and 3D), pixel
values, area of ROI
(rectangle, circle,
ellipse), volume | Ruler (line and 3D),
Tapeline (curve,
poly and3D), Angle
(3-point, 4point, and
3D), pixel
values, area of ROI
(rectangle, circle,
ellipse), volume | | Ruler (line and 3D),
Tapeline (curve, poly
and3D), Angle (3-
point, 4point, and 3D),
pixel values, area of
ROI (rectangle, circle,
ellipse), volume | | | | | | | | | |
| Indications for
use | AVIEW 2.0
AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software could be used to support the physician
quantitatively in the diagnosis, follow up evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in
lung, lobe, airways and cardiac, registration of inspiration and expiration which could analyze air trapping on lung, volumetric and structure analysis,
density evaluation and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise and as cloud environment as
well to allow users to connect by various environment such as mobile devices and chrome browser. Characterizing nodules in the lung in a single study,
or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major
axis, minor axis), estimated effective diameter from the volume of the nodule, volume of the nodule, Mean HU(the average value of the CT pixel inside
the nodule in HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric measures(Solid major; length of the longest
diameter measured in 3D for solid portion of the nodule, Solid 2nd Major: The length of the longest diameter of the solid part, measured in sections
perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with
findings). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA
certified Mevis CAD (Computer aided detection) (K043617). It also provides CAC analysis by segmentation of four main artery (right coronary artery,
left main coronary, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score
and mass score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.

AVIEW
AVEIW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the
diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung
(e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire
and display CT data sets. AVEIW is not meant for primary image Interpretation in mammography.

Imbio CT Lung Density Analysis Software
The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative
support for diagnosis follow up examinations. The Imbio CT Lung Density Analysis Software can be used to support the physician in the diagnosis and
documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments,
volumetric analysis, density evaluation, and reporting tools are provided.

AVEIW LCS
AVIEW LCS is intended for the review and analysis and reporting of thoracic CT images for the purpose of characterizing nodules in the lung in a single
study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size
(major axis, minor axis), estimated effective diameter from the volume of the nodule, the volume of the nodule, Mean HU(the average value of the CT
pixel inside the nodule in HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric measures (Solid Major, length
of the longest diameter measured in 3D for a solid portion of the nodule. Solid 2nd Major: The length of the longest diameter of the solid part, measured
in sections perpendicular to the Major axis of the solid portion of the nodule), VDT(Volume doubling time), and Lung-RADS (classification proposed
to aid with findings). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, also integrate
with FDA certified Mevis CAD (Computer-aided detection) (K043617)

AI-Rad Companion (Cardiovascular)
Al-Rad Companion (Cardiovascular) is processing software that provides quantitative and qualitative analysis from previously acquired Computed
Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the
evaluation and assessment of cardiovascular disease.
It provides the following functionality:
· Segmentation and volume measurement of the heart
· Quantification of the total calcium volume in the coronary arteries
· Segmentation of the aorta
· Measurement of maximum diameters of the aorta at typical landmarks
· Threshold-based highlighting of enlarged diameters

The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Helathineers, GE Healthcare,
Philips, and Toshiba/Canon, Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction
form Siemens Healthineers.

Only DICOM images of adult patients are considered to be valid input.

Calcium Scoring
From user specified sets of CT cardiac images, Calcium Scoring can be used to;
· Allow the user to interactively indicate regions of detected calcification
· To allow the user to allocate each detected region to one of several coronary arteries
· To estimate algorithmically a score for the amount of detected calcification in each allocated artery
· To prepare reports including reports including calcium score data, Imagery, ECG traces, Comparison of scroe to cited literature and additional
relevant information.
The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for
coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the
coronary arteries, which may be related to the prognosis of a cardiac attack. | | | | | | | Image viewing | Axial, sagittal, and
coronal image, oblique
slice, cube view | Axial, sagittal, and
coronal image,
oblique slice, cube
view | | Axial, sagittal, and
coronal image, oblique
slice, cube view | | | | | | | | |
| Platform | IBM-compatible PC or
PC network | IBM-compatible PC
or PC network | IBM-compatible PC or
PC network | IBM-compatible PC or
PC network | IBM-compatible PC
or PC network | IBM-compatible PC
or PC network | Image
manipulation | Panning, rotating,
zooming, windowing,
inverting, Coloring,
Oblique, Note (text
overlay), Coloring | Panning, rotating,
zooming, windowing,
inverting, Coloring,
Oblique, Note (text
overlay), Coloring | | Panning, rotating,
zooming, windowing,
Coloring, Oblique,
Note (text
overlay), Coloring | | | | | | | | | |
| General
Description | AVIEW 2.0
The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM
3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing,
saving and sending images by using the software tools. And is intended for use as diagnostic patient imaging which is intended for the review and analysis
of CT scanning. Provides following features as semi-automatic nodule management, maximal plane measure, 3D measures and volumetric measures,
automatic nodule detection by integration with 3rd party CAD. Also provides Brocks model which calculated the malignancy score based on numerical
or Boolean inputs. Follow up support with automated nodule matching and automatically categorize Lung-RADS score which is a quality assurance tool
designed to standardize lung cancer screening CT reporting and management recommendations that is based on type, size, size change and other findings
that is reported. It also automatically analyzes coronary artery calcification which support user to detect cardiovascular disease in early stage and reduce
the burden of medical.
AVIEW
The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM
3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading. Manipulation, analyzing, post-processing,
saving and sending images by using the software tools.
Imbio CT Lung Density Analysis Software
The Imbio CT Lung Density Analysis Software (Imbio LDA) IS A SET OF IMAGE POST-PROCESSING ALGORITHMS THAT PERFORM IAMGE
SEGMENTATION, REGISTRATION, THRESHOLDING, AND CLASSIFICATION ON ct images of juman lungs.
The algorithms within the Imbio CT Lung Density Analysis Software are combined into a single command-line or through scripting. The Imbio CT Lung
Density Analysis Software program performs segmentation, then registration, then thresholding and classification. The program reads in DICOM
datasets, processes the data, then writes output DICOM files to a specified directory.
The Imbio CT Lung Density Analysis Software is a command-line software application that analyzed DICOM CT Lung images datasets and generated
reports and DICOM output that show the lungs segmented and overlaid with colorpcodings representing the results of its thresholding and classification
rules. It has simple file management functions for input and output, and separate modules that implement the CT image-processing algorithms. Imbio
CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files
previously generated by such equipment.
AVIEW LCS
AVIEW LCS is intended for use as diagnostic patient imaging which is intended for the review and analysis of thoracic CT images. Provides following
features as semi-automatic nodule measurement (segmentation), maximal plane measure, 3D measure and volumetric measures, automatic nodule
detection by integration with 3rd party CAD. Also provide cancer risk based on PANCAN risk model which calculated the malignancy score based on
numerical or Boolean inputs. Follow up support with automated nodule matching and automatically categorize Lung-RADS score which is a quality
assurance tool designed to standardize lung cancer screening CT reporting and management recommendations that is based on type, size, size change
and other findings that is reported.
AI-Rad Companion (Cardiovascular)
In general, AI-Rad Companion (Cardiovascular) is a software only image post-processing application that uses deep learning algorithms to post-process
CT data of the thorax. As an update to the previously cleared devices, the following modifications have been made; | | | | | | | | | | | | | | | | | | | |
| | 1) Modified indication for Use Statement
2) Support of software AI-Rad Companion CT VA10A
a) heart segmentation including measurement (modified)
b) calcium detection based on deep learning algorithm (modified) | | | | | | | | | | | | | | | | | | | |

8

9

Coreline

10

| | | d) AHA landmarks for labeling and diameter measurement of the aorta, including threshold-based aorta diameter classification (modified)
3) subject device claims list
The subject device AI-Rad Companion (Cardiovascular) is an image processing software that utilizes deep learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM image to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the thorax. The subject device support the following device specific functionality. | | | | | |
|--|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|
| | | Segmentation and volume measurement of heart
Identification and measurement of volume with high Hounsfield values- related to coronary calcification
Segmentation of the aorta determination of 9 Landmarks.
Computation of cross-sectional MPRs at the 9 landmarks and their maximum diameter
Measurement of maximum diameters of the aorta at typical landmakrs.
Threshold-based classification of diameters into different categories | | | | | |
| | | Calcium Scoring
Calcium Scoring is a software package running on the 3Dvirtuoso workstation that allows the user to mark regions of detected calcification in CT cardiac images, to assign each region to a coronary artery, and to calculate the Agatston score and other information from the identified pixels. Film and paper reports of the results can also be prepared. Calcium Scoring is also a cost-effective alternative to Electron Beam CT (EBCT), since it produces calcium scores that correlated to the EBCT's gold standard, but at a much lower cost. | | | | | |
| | DICOM | This receives DICOM data from CT by DICOM communication
Conducts DICOM data communication with PACS. It also imports DICOM file directly, saves by using export function. | This receives DICOM data from CT by DICOM communication
Conducts DICOM data communication with PACS. It also imports DICOM file directly, saves by using export function. | Retrieve image data over the network via DICOM | This receives DICOM data from CT by DICOM communication
Conducts DICOM data communication with PACS. It also imports DICOM file directly, saves by using export function. | Retrieve image data over the network via DICOM | Retrieve image data over the network via DICOM |
| | | Fully automatic lungs, lobes and airways segmentation using deep-learning algorithms | Semi-automatic segmentation of lungs, lobes and airways. | | | | |
| | | Semi-automatic segmentation of lungs, lobes and airways. | | | | | |
| | | Visualization of multi-planar reconstructed (MPR) images and 3D rendered images, with color-defined Hounsfield Unit (HU) ranges. | Visualization of multi-planar reconstructed (MPR) images and 3D rendered images, with color-defined Hounsfield Unit (HU) ranges. | | | | |
| | Lung Analysis
Functions | Calculation of LAA (Lower Attenuation Area) index with HU density histogram. Volume measurements and percentile index | Calculation of LAA (Lower Attenuation Area) index with HU density histogram. Volume measurements and percentile index | | | | |
| | | Calculation of LAA cluster size distribution with D-slope | Calculation of LAA cluster size distribution with D-slope | | | | |
| | | Graphical visualization of the above quantification results for reporting | Graphical visualization of the above quantification results for reporting | | | | |
| | | Export of quantification results to CSV tables | Export of quantification results to CSV tables | | | | |
| | | Visualization of LAA% for each of 5 lobes | Visualization of LAA% for each of 5 lobes | | | | |
| | | Measurements of the airway branches, such as, lumen area and wall area | Measurements of the airway branches, such as, lumen area and wall area | | | | |

11

Coreline

| | Analyzes Air Trapping
Index by registration of
inspiration and
expiration data. Could
compare both IN/EX
after the registration | Imbio provides
segmentation of lung
and automatied
registration of
inspiration and
expiration image part to
classify the analysis by
thresholding the CT
data.
It also provides an
interctive visualliztion
of the registered pairs to
analyze low-density
cluster (air trap) and
airway analysis.
Uses advanced image | | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--|
| | Fully automatic
INSP/EXP registration
(non-rigid elastic)
algorithm. | processing techniques
to spatially "register"
two CT image of the
lungs. | | |
| | Fully automatic
lung/lobe segmentation
using deep-learning
algorithms | | same | |
| | Automatic calculation of
measurements for each
segmented nodule
· Size of the Major axis
and Minor axis(mm)
· Diameter of Major
(3D), 2nd Major
(3D), Major(2D),
Minor(2D) (mm)
· Volume(mm³)
· Max, Min, Mean HU
of the nodule((HU)
Cancer probability (%) | | same | |
| Lung
Cancer
Screening | Comparison and
matching automatic
calculations between
each follow-up scan and
the baseline scan
· Doubling time in
days
· Indicated the change
of the size
Auto generate Lung-
RADS | | Same | |
| | Loading multiple studies | | Same | |
| | Workflow
· Detect and Segment
· Comparison and
Matching
· Results
Option to integrate with
3rd party CAD which
automatically detects the
nodules and generate
report | | Same | |
| | Supporting Low-dose
CT | | Same | |
| | Reporting results
The results include the
following;
· Lung-RADS
· PANCAN risk
calculator
· Auto detect nodule
location by lobe | | Same | |

12

Image /page/12/Picture/0 description: The image shows the word "CORELINE" in white text on a dark blue background. To the left of the word is a triangular shape that is also white. The triangular shape is made up of three lines that are connected at the corners.

| Cardiac (CAC) | Extracting Calcium on
Coronary Artery and
provides Agatston score,
volume score and mass
score. | - | - | Extracting Calcium
on Coronary Artery
and provides
Agatston score and
volume score | evaluation and
documentation of
calcified coronary
lesions, calculation
of the Agatston
equivalent
score |
|---------------|-------------------------------------------------------------------------------------------------------------|---|---|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Automatically segments
calcium area of coronary
artery based on deep
learning. | | - | Calcium Detection
deep learning-based
algorithm | |

PERFORMANCE DATA 8

8.1 Nonclinical Performance Testing

This Medical device is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing

8.2 Software Verification and Validation

Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified device passed all of the tests based on pre-determined Pass/Fail criteria.

-Unit Test
Conducting Unit Test using Google C++ Unit Test Framework on major software components identified by software development team. List of Unit Test includes Functional test condition for software component unit, Performance test condition, and part of algorithm analysis for image processing algorithm.
System Test -
In accordance with the document 'integration Test Cases' discussed in advanced by software development team and test team, test is conducted by installing software to hardware with recommended system specification. Despite Test case recognized in advance was not in existence. New software error discovered by 'Exploratory Test' conducted by test team will be registered and managed as new test case after discussion between development team and test team.

Discovered software error will be classified into 3 categories as severity and managed.

Major defects, which are impacting the product's intended use and no workaround is available.
Moderate defects, which are typically related to user-interface or general quality of product, while workaround is available.
Minor defects, which aren't impacting the product's intended use. Not significant.

Success standard of System Test is not finding 'Major', 'Moderate' defect.

Performance Test
- · Auto Lung & Lobe Segmentation
- Airway Segmentation .
- Nodule Matching Experiment Using Lung Registration .
- Validation on DVF Size Optimization with Sub-sampling ●
- Semi-automatic Nodule Segmentation

13

Brock Model (ask PANCAN) Calculation .
VDT Calculation .
. Lung RADS Calculation
Validation LAA Analysis ●
Validation LAA Size Analysis ●
Size analysis algorithm of LAA clusters ●
Lung Registration
Reliability Test for Airway wall Measurement
CAC Performance ●
Air Trapping Analysis .

CONCLUSIONS 9

The new device and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the AVIEW described in this submission is substantially equivalent to the predicate device.