# K212758: Autoplaque

- Pathway: 510(k) (Traditional)
- Applicant: Cedars-Sinai Medical Center: Aim
- Decided: May 19, 2023 after 626 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: 11 generations back to K913770 (1991). 68 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122429: Vessel Analysis and Autoplaque for Ors Visual, Object Research Systems (Ors), Inc. (2012) Summary page 4.

## Most influential descendants
- K242240: CaRi-Plaque (2025), 1 descendant of its own
- K260497: DEEPVESSEL Plaque (2026), 0 descendants of its own
- K251837: Salix Coronary Plaque (V1.0.0) (2025), 0 descendants of its own

## Indications for use
Autoplaque 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. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. 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. Autoplaque must be installed on a suitable commercial computer platform. It is the user’s responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K212758
Methodology: https://510kreport.com/methodology