# K214036: AVIEW

- Pathway: 510(k) (Traditional)
- Applicant: Coreline Soft Co., Ltd.
- Decided: Dec 23, 2022 after 365 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954355 (1995). 14 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200714: AVIEW, Coreline Soft Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K233211: Aview Cac (2024), 2 descendants of its own
- K250288: TeraRecon Cardiovascular.Calcification.CT (2025), 0 descendants of its own
- K243689: AVIEW (2025), 0 descendants of its own
- K243696: Aview Cac (2025), 0 descendants of its own

## Indications for 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 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.

Source page: https://510kreport.com/device/K214036
Methodology: https://510kreport.com/methodology