Who is the manufacturer of A View LCS?

Coreline Soft Co., Ltd. filed the 510(k) submission for A View LCS (K201710).

What is the FDA product code for A View LCS?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for A View LCS?

510(k) clearance (submission type: Traditional).

Does A View LCS use AI or machine learning?

Yes. A View LCS (K201710) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like A View LCS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like A View LCS get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

A View LCS

K201710 · Coreline Soft Co., Ltd. · LLZ · Oct 16, 2020 · Radiology

Device Facts

Record ID	K201710
Device Name	A View LCS
Applicant	Coreline Soft Co., Ltd.
Product Code	LLZ · Radiology
Decision Date	Oct 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

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), estimated effective diameter from the volume of 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 nodule), VDT (Volume doubling time), Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. 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).

Device Story

AVIEW LCS is a software-based radiological image processing system for thoracic CT analysis. It accepts DICOM-formatted thoracic CT images as input. The device performs semi-automatic nodule segmentation, 3D/volumetric measurements, and automatic nodule matching for follow-up studies. It integrates with third-party CAD for automatic nodule detection. The system calculates malignancy scores using the PANCAN risk model and categorizes findings using Lung-RADS. It also performs CAC (coronary artery calcification) scoring and LAA (low attenuation area) analysis. Used in clinical settings, the software operates on a thin-client architecture, accessible via web browsers or mobile devices. Healthcare providers use the generated PDF reports and DICOM-integrated images to standardize lung cancer screening reporting, track nodule growth (VDT), and support clinical decision-making regarding patient management. The device benefits patients by providing standardized, quantitative analysis of lung nodules and cardiovascular risk markers, facilitating early detection and consistent follow-up.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical performance testing, including software verification and validation (unit and system testing) and DICOM compatibility testing.

Technological Characteristics

Software-based image processing system; operates on IBM-compatible PC/network; supports thin-client/cloud/mobile access. Features include semi-automatic segmentation, 3D/volumetric measurement, and rule-based automatic processing server (APS). Integrates with third-party CAD. DICOM 3.0 compliant. Software includes deep-learning algorithms for lung/lobe segmentation and PANCAN risk model for malignancy scoring.

Indications for Use

Indicated for review, analysis, and reporting of thoracic CT images to characterize lung nodules in single or longitudinal studies. Applicable to patients undergoing thoracic CT imaging for lung nodule assessment. No specific contraindications listed.

Regulatory Classification

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 LCS (K193220)

Reference Devices

Lung Nodule Assessment and Comparison Option (LNA) (K162484)
AVIEW (K200714)
Mevis CAD (K043617)

Related Devices

K193220 — AVIEW LCS · Coreline Soft Co., Ltd. · May 5, 2020
K214036 — AVIEW · Coreline Soft Co., Ltd. · Dec 23, 2022
K243689 — AVIEW · Coreline Soft Co., Ltd. · Mar 19, 2025
K200714 — AVIEW · Coreline Soft Co., Ltd. · Aug 26, 2020
K162484 — Lung Nodule Assessment and Comparison Option (LNA) · Philips Medical Systems Nederland B.V. · Feb 23, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ October 16, 2020 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "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 03991 REPUBLIC OF KOREA Re: K201710 Trade/Device Name: AView LCS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: June 22, 2020 Received: September 14, 2020 Dear Hye Yi 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 may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201710 Device Name AVIEW LCS ### Indications for Use (Describe) 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), estimated effective diameter from the volume of 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 nodule), VDT (Volume doubling time), Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. 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). | 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." {3}------------------------------------------------ # 006_510(k) Summary Image /page/3/Picture/1 description: The image shows the Coreline logo. The logo consists of a blue triangle shape on the left and the word "CORELINE" in blue on the right. The triangle shape is made up of three different shades of blue, with the darkest shade on the left and the lightest shade on the right. {4}------------------------------------------------ # 510(k) Summary #### SUBMITTER 1 K201710 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: 06.22.2020 #### 2 DEVICE 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 #### PREDICATE DEVICE 3 AVIEW LCS by Coreline 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 This predicate has not been subject to a design-related recall #### REFERENCE DEVICE 4 Lung Nodule Assessment and Comparison Option by Philips Medical System Nederland B.V. (K 162484) Name of Device: Lung Nodule Assessment and Comparison Option (LNA) Common or Usual Name: Lung Nodule Assessment and Comparison Option (LNA) Classification Name: System, image processing, radiological (21CFR 892.1750) Regulatory Class: II Product Code: LLZ, JAK {5}------------------------------------------------ # AVIEW by Coreline Soft Co., Ltd. (K200714) Name of Device: AVIEW Common or Usual Name: AVIEW Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ, JAK All reference devices have not been subject to a design-related recall. #### DEVICEW DESCRIPTION 5 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 nodules detection by integration with 3th party CAD. Also provides cancer risk based on PANCAN risk model which calculates 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. - -Easy processing management - Rule-based automatic processing server (APS) " - -Thin client service - Connected from anywhere, anyplace, anytime. . - . Support mobile view through various mobile device served by Ios and Android. - Compatible with Chrome browser . - -Nodule measurement - " Adding nodule by segmentation or by lines - . Semi-automatic nodule measurement (segmentation) - Maximal plane measure, 3D measure and volumetric measure. . - י 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 - -CAC, LAA on LC - Displays CAC score which was analyzed " - . Displays LAA available which was analyzed {6}------------------------------------------------ - -Follow-up - י Automatic retrieving the past data - Follow-up support with nodule matching and comparison . - . Automatic calculation of VDT (volume doubling time) - -Automatic nodule detection (CADe) - Seamless integration with Mevis Visia (FDA 510k Cleared) - -Lungs and lobes segmentation - Better segmentation of lungs and lobes based on deep-learning algorithms. - -Report - י PDF report generation - י It saves or sends the pdf report and captured images in DICOM files. - Reports are generated using the results of all nodules nodules detected so far (Lung RADS) . - Save Result - - . It saves the results in internal format #### INDICATIONS FOR USE 6 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), estimated effective diameter from the volume of the volume of the nodule, Mean HU (the average value of the CT pixel inside the nodule in HU), Minimum HU, Max (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 solid portion of the nodule), VDT (Volume doubling time), Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. 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). ### COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH 7 THE PREDICATE DEVCIE AVIEW LCS has the same intended use and the principle of operation, and also has similar features to the predicate devices. Lung Nodule Assessment and Comparison Option (LNA) (K162484) 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 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------|---------------------------------------------| | Device Name | AVIEW LCS | AVIEW LCS | Lung Nodule Assessment and Comparison Option (LNA) | AVIEW | | Classification Name | System, image Processing Radiological | System, image Processing Radiological | System, image Processing Radiological | System, image Processing Radiological | | Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Product Code | LLZ, JAK | LLZ, JAK | LLZ, JAK | LLZ, JAK | | Review Panel | Radiology | Radiology | Radiology | Radiology | | 510k Number | - | K193220 | K162484 | K200714 | | Indications for use | AVIEW 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), Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. 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). | | | | | | AVIEW 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). | | | | | | Lung Nodule Assessment and Comparison Option (LNA) The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient- imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. | | | | | | AVIEW 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 trapping volume, 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 | | | | {7}------------------------------------------------ {8}------------------------------------------------ | 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. | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | 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 | | User interface | Monitor, Mouse, Keyboard | Monitor, Mouse, Keyboard | Monitor, Mouse, Keyboard | Monitor, Mouse, Keyboard | | Image Input Soures | 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 | | Image format | DICOM | DICOM | DICOM | DICOM | | Intended body part | chest | chest | chest | chest | | Type of Scans | CT | CT | CT | CT | | General Description | 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 columetric measures, automatic nodules detection by integration with 3rd party CAD. Also provides cancer risk based on PANCAN risk model which calculates 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. 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 columetric measures, automatic nodules detection by integration with 3rd party CAD. Also provides cancer risk based on PANCAN risk model which calculates 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. Lung Nodule Assessment and Comparison Option (LNA) The Lung Nodule Assessment and Comparison Option application is intended for use as a diagnostic patient imaging tool. It is intended for the review and analysis of thoracic CT images, | | | | | | | | | | | or over the time course of several thoracic studies. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The user interface and automated tools help to determine growth patterns and compose comparative reviews. The Lung Nodule Assessment and Comparison Option application requires the user to identify a nodule and to determine the type of nodule in order to use the appropriate characterization tool. Lung Nodule Assessment and Comparison Option may be utilized in both diagnostic and screening evaluations supporting Low Dose CT Lung Cancer Screening 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. 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. | | | | | | | | | | | | | Providing ray sum image, axial, sagittal, coronal, and oblique planes. | same | Providing axial, sagittal, coronal, and oblique planes | same | |…