# K233211: Aview Cac

- Pathway: 510(k) (Traditional)
- Applicant: Coreline Soft Co., Ltd.
- Decided: Mar 29, 2024 after 183 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: 11 generations back to K954355 (1995). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214036: AVIEW, Coreline Soft Co., Ltd. (2022) Summary page 4.

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

## Indications for use
A VIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest er scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, transferring, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing non-contrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to er scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.

Source page: https://510kreport.com/device/K233211
Methodology: https://510kreport.com/methodology