# K251027: cvi42 Coronary Plaque Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Oct 27, 2025 after 208 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: 12 generations back to K913770 (1991). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 5.
- K190868: Cleerly Labs, Cleerly, Inc. (2019) Summary page 5.

## Indications for use
cvi42 Coronary Plaque Software Application is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables a set of tools to assist physicians in qualitative and quantitative assessment of cardiac CT images to determine the presence and extent of coronary plaques and stenoses, in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. cvi42 Coronary Plaque’s semi-automated machine learning algorithms are intended for an adult population. cvi42 Coronary Plaque shall be used only for cardiac images acquired from a CT scanner. It shall be used by qualified medical professionals, experienced in examining cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.

Source page: https://510kreport.com/device/K251027
Methodology: https://510kreport.com/methodology