# K242240: CaRi-Plaque

- Pathway: 510(k) (Traditional)
- Applicant: Caristo Diagnostics, Ltd.
- Decided: Feb 20, 2025 after 205 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212758: Autoplaque, Cedars-Sinai Medical Center: Aim (2023) Summary page 4.

## Most influential descendants
- K251837: Salix Coronary Plaque (V1.0.0) (2025), 0 descendants of its own

## Indications for use
CaRi-Plaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CaRi-Plaque is a web-based image processing application. It is a non-invasive diagnostic reading software intended for use as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. CaRi-Plaque is intended for use by internal operators who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology may be present that is near or smaller than the scanning resolution. The analysis results produced by the software and provided to the Healthcare Professional are not intended to replace the skill and judgment of a qualified medical practitioner. The analysis results should be reviewed with other clinical information which may include but is not limited to: The patient's original CT images, clinical history, symptoms, clinical risk factors, results of other diagnostic tests, and the clinical judgement of appropriately qualified Healthcare Professionals.

Source page: https://510kreport.com/device/K242240
Methodology: https://510kreport.com/methodology