# K202280: Cleerly Labs v2.0

- Pathway: 510(k) (Traditional)
- Applicant: Cleerly, Inc.
- Decided: Oct 2, 2020 after 52 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.
5 later devices descend from it; 3 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190868: Cleerly Labs, Cleerly, Inc. (2019) Summary page 4.

## Most influential descendants
- K242338: Cleerly LABS (v2.0) (2025), 2 descendants of its own
- K261210: Cleerly Plaque (2026), 0 descendants of its own
- K260588: Cleerly LABS (2026), 0 descendants of its own
- K253786: syngo.CT Coronary Cockpit (2026), 0 descendants of its own
- K251656: Careverse CoronaryDoc (Careverse CoronaryDoc) (2025), 0 descendants of its own

## Indications for use
Cleerly Labs is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software 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 people 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 that is near or smaller than the scanning resolution may be present.

Source page: https://510kreport.com/device/K202280
Methodology: https://510kreport.com/methodology