# K260588: Cleerly LABS

- Pathway: 510(k) (Traditional)
- Applicant: Cleerly, Inc.
- Decided: Jul 29, 2026 after 159 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: 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 LABS is a web-based software application intended to be used by trained medical professionals as an interactive tool for processing, analyzing and viewing cardiac computed tomography (CT) data to assess coronary anatomy in patients who have undergone Coronary Computed Tomography Angiography (CCTA) for the evaluation of coronary artery disease (CAD) or suspected CAD. This software post-processes CT images obtained from a CT scanner and provides tools for the measurement and visualization of coronary arteries. 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 data set. 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/K260588
Methodology: https://510kreport.com/methodology