Who is the manufacturer of AVIEW?

Coreline Soft Co., Ltd. filed the 510(k) submission for AVIEW (K214036).

What is the FDA product code for AVIEW?

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

What is the regulatory pathway for AVIEW?

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

Does AVIEW use AI or machine learning?

Yes. AVIEW (K214036) 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 AVIEW?

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 AVIEW 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.

AVIEW

K214036 · Coreline Soft Co., Ltd. · QIH · Dec 23, 2022 · Radiology

Device Facts

Record ID	K214036
Device Name	AVIEW
Applicant	Coreline Soft Co., Ltd.
Product Code	QIH · Radiology
Decision Date	Dec 23, 2022
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 provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the sharp kernel for quantitative analysis of segmenting low attenuation areas of the lung. Characterizing nodules in the lung in a single study or over the time course of several thoracic studies. Characterizations include 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 measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size 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 the Agatston score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left main coronary, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender. The device is indicated for adult patients only.

Device Story

AVIEW is a software-based medical device for quantitative analysis of thoracic and cardiac CT images. It ingests DICOM 3.0 datasets; performs automated segmentation of lungs, lobes, airways, and coronary arteries; and calculates metrics including nodule volume, density (HU), mass, VDT, and Lung-RADS scores. It also computes Agatston, volume, and mass scores for coronary artery calcification. The software operates on PCs or via cloud-based environments accessible through mobile devices and web browsers. Physicians use the output to support diagnosis, follow-up, and lung cancer screening management. It integrates with third-party CAD systems for nodule detection. The device benefits patients by standardizing reporting, enabling longitudinal nodule tracking, and providing automated cardiovascular risk assessment, thereby reducing physician workload and improving diagnostic consistency.

Clinical Evidence

Bench testing only. No clinical studies were conducted. Performance was validated through software verification and system testing, including nodule matching, LAA comparative experiments, fissure completeness (using 129 subjects from the TCIA LIDC database, evaluated via Bland-Altman, Kappa, and ICC), and kernel conversion reliability.

Technological Characteristics

Software-based image processing system; DICOM 3.0 compliant; operates on IBM-compatible PCs or cloud-based environments. Features include deep-learning-based segmentation of lungs, lobes, and airways; rule-based automatic processing server (APS); and integration with third-party CAD. Supports kernel conversion for quantitative analysis.

Indications for Use

Indicated for adult patients. Supports physicians in quantitative analysis of thoracic and cardiac CT images, including lung/lobe/airway segmentation, nodule characterization, Lung-RADS classification, and coronary artery calcium (CAC) scoring.

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 (K200714)

Reference Devices

ClariCT.AI (K183460)
Broncholab (K191550)
Mevis CAD (K043617)

Related Devices

K243689 — AVIEW · Coreline Soft Co., Ltd. · Mar 19, 2025
K200714 — AVIEW · Coreline Soft Co., Ltd. · Aug 26, 2020
K201710 — A View LCS · Coreline Soft Co., Ltd. · Oct 16, 2020
K193220 — AVIEW LCS · Coreline Soft Co., Ltd. · May 5, 2020
K171199 — AVIEW · Coreline Soft Co., Ltd. · Oct 31, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text. Coreline Soft Co., Ltd. % Hye Yi Park RA Manager 4,5F(Yeonnam-dong), 49, World Cup buk-ro 6-gil Mapo-gu Seoul, 03991 KOREA Re: K214036 Dec. 23, 2022 Trade/Device Name: AVIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, JAK Dated: November 25, 2022 Received: November 28, 2022 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. Wenbo Li for Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. # 510(k) Number (if known) K214036 Device Name AVIEW ## Indications for Use (Describe) AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the sharp kernel for quantitative analysis of segmenting low attenuation areas of the lung. Characterizing nodules in the lung in a single study or over the time course of several thoracic studies. Characterizations include 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 measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size 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 the Agatston score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left main coronary, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender. The device is indicated for adult patients only. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # 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}------------------------------------------------ # 510(k) Summary K214036 #### 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: 12.21.2022 #### DEVICE 2 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: QIH, JAK #### 3 PREDICATE DEVICE AVIEW by Coraline Soft Co., Ltd. (K200714) 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 This predicate has not been subject to a design-related recall #### REFERENCE DEVICE 4 ClariCT.AI by ClariPI Inc.(K183460) Name of Device: ClariCT.AI Common or Usual Name: Image Processing Software Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ {4}------------------------------------------------ Broncholab by Fluidda Inc.(K191550) Name of Device: Broncholab Common or Usual Name: Image Processing Software 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 #### DEVICE DESCRIPTION 5 The AVIEW is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, 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 software tools. And is intended for use as a quantitative analysis of CT scanning. It provides the following features such as segmentation of lung, lobe, airway, fissure completeness, semi-automatic nodule management, maximal plane measures and volumetric measures, automatic nodule detection by integration with 3rd party CAD. It also provides the Brocks 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 are based on type, size, size, size, size, size, size, size, size, size, size, size, size change, and other findings that are reported. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries #### INDICATIONS FOR USE 6 AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung. lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the soft kernel for quantitative analysis of segmenting low attenuation areas of the lung. Characterizing nodules in the lung in a single study or over the time course of several thoracic studies. Characterizations include type, location of the nodule, and measurements such as size (major 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), Max HU, mass(mass calculated from the CT pixel value), and volumetric measures(Solid major, length of the longest diameter measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size of the solid part, measured in sections perpendicular to the Major axis 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 the Agatston score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender. The device is indicated for adult patients only. {5}------------------------------------------------ # COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH 7 THE PREDICATE DEVCIE AVIEW has the same intended use and the principle of operation and has similar features to the predicate devices. AVIEW (K200714) 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 | Predicate Device | Reference Device | Reference Device | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|-------------------------------------------| | Device Name | AVIEW | AVIEW | ClariCT.AI | Broncholab | | Classification Name | System, image Processing Radiological | System, image Processing Radiological | System, image Processing Radiological | System, X-Ray, Tomography, Computed | | Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1750 | | Product Code | QIH, JAK | LLZ, JAK | LLZ | JAK | | Review Panel | Radiology | Radiology | Radiology | Radiology | | 510k Number | - | K200714 | K183460 | K191550 | | Indications for use | AVIEW AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the sharp kernel to soft kernel for quantitative analysis of segmenting low attenuation areas of the lung. 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 measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size 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 the Agatston score, volume score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left main coronary, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender. The device is indicated for adult patients only. | | | | {6}------------------------------------------------ | General Description | 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, 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. | |-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ClariCT.AI ClariCT.AI, is a software device intended for networking, communication, processing, and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. | | | Broncholab | | | Broncholab provides physicians with reproducible CT values for pulmonary tissue for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow. | | | AVIEW | | General Description | The AVIEW is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, 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 software tools. And is intended for use as a quantitative analysis of CT scanning. It provides the following features such as segmentation of lung, lobe, airway, fissure completeness, semi-automatic nodule management, maximal plane measure, 3D measures and volumetric measures, automatic nodule detection by integration with 3rd party CAD. It also provides the Brocks 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 are based on type, size, size change, and other findings that are reported. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries. | | | 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. | | | Callery of Children Company of Children | | {7}------------------------------------------------ ## ClariCT.AI ClariCT.AI software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.AI software can be used to reduce noises in CT images of the head, chest, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.AI may also improve the image quality of low dose nonpdiagnostic Filtered Back Projection images as well as Iterative Reconstruction images. The system enables the receipt of DICOM images from CT imaging devices (modalities), enables their denoise processing and enhancement, and transmission to a PACS workstation. # Broncholab Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans. The CT scan images are transformed into 3D models of the patient-specific lungs using several image processing steps. Broncholab can be used to assess the effectiveness of therapy based on CT scan data. It is used along with the following accessories: - Web Portal: Enables the uploading of CT scans and patient data - . Client Report: Enables the conversion of the output of Broncholab (CT values) into a desired digital format (PDF Report) and transfers this Report to the physician via email. Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airw…