# K260497: DEEPVESSEL Plaque

- Pathway: 510(k) (Traditional)
- Applicant: Keya Medical Technology Co., Ltd.
- Decided: Jun 4, 2026 after 111 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). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 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 5.

## Indications for use
DEEPVESSEL Plaque is a coronary analysis software developed for the analysis of Computed Tomography Angiography (CTA) DICOM data for patients aged 22 and above with suspected or known coronary artery disease (CAD). It provides presence and extent of coronary plaques and stenosis in patients who underwent CCTA for evaluation of suspected or known CAD. Users should be aware that certain views make use of interpolated data. This is data that is created by 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. The results of the analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. DEEPVESSEL Plaque results are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. The software is not intended to replace the skill and judgement of a qualified medical practitioner and should only be used by people who have been appropriately trained to use the software.

Source page: https://510kreport.com/device/K260497
Methodology: https://510kreport.com/methodology