# K261210: Cleerly Plaque

- Pathway: 510(k) (Traditional)
- Applicant: Cleerly, Inc.
- Decided: Jul 29, 2026 after 106 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: 14 generations back to K913770 (1991). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242338: Cleerly LABS (v2.0), Cleerly, Inc. (2025) Summary page 5.

## Indications for use
Cleerly Plaque is a software module used in conjunction with Cleerly LABS, designed to assist in the evaluation of coronary artery disease (CAD) by identifying, characterizing, and quantifying coronary plaque in patients undergoing coronary computed tomography angiography (CCTA). The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by medical professionals experienced in examining and evaluating cardiac CT images. 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 dataset. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Source page: https://510kreport.com/device/K261210
Methodology: https://510kreport.com/methodology