← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K200714 # AVIEW (K200714) _Coreline Soft Co., Ltd. · LLZ · Aug 26, 2020 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K200714 ## Device Facts - **Applicant:** Coreline Soft Co., Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Aug 26, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML, Software as a Medical Device ## Intended Use 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(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. ## Device Story AVIEW is PC-based software for processing/analyzing thoracic and cardiac CT DICOM datasets. It performs semi-automatic nodule management, volumetric/structural analysis, and CAC scoring. Inputs are CT images; outputs are quantitative measurements (nodule size, volume, HU, VDT, Lung-RADS scores, Agatston/volume/mass scores for CAC). Operates via deep-learning algorithms for lung/lobe/airway segmentation and CAC calcium extraction. Used by physicians in clinical settings to support diagnosis and follow-up. Supports on-premise and cloud-based access via mobile/web browsers. Integrates with third-party CAD (Mevis). Benefits include standardized reporting, automated quantification, and early cardiovascular disease detection. ## Clinical Evidence Bench testing only. No clinical studies were conducted. Substantial equivalence established through non-clinical software verification and validation, including unit testing (Google C++ Framework), system testing, and performance testing of segmentation, registration, and calculation algorithms. ## Technological Characteristics PC-based software; DICOM 3.0 compliant. Uses deep-learning algorithms for lung/lobe/airway segmentation and CAC calcium extraction. Features non-rigid elastic registration for INSP/EXP analysis. Supports web-based thin-client access (mobile/Chrome). ## 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 - AVIEW ([K171199](/device/K171199.md)) ## Reference Devices - Imbio CT Lung Density Analysis Software ([K141069](/device/K141069.md)) - AVIEW LCS ([K193220](/device/K193220.md)) - AI-Rad Companion (Cardiovascular) ([K183268](/device/K183268.md)) - Calcium Scoring ([K990426](/device/K990426.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}------------------------------------------------ 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)
| |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ ## 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… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K200714](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K200714) **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