# K241524: Elucid PlaqueIQ

- Pathway: 510(k) (Traditional)
- Applicant: Elucid Bioimaging, Inc.
- Decided: Sep 12, 2024 after 106 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.
No later device cites it as a predicate yet.
0 of 69 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 5.

## Indications for use
Elucid PlaqueIQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

Source page: https://510kreport.com/device/K241524
Methodology: https://510kreport.com/methodology