# K122022: Atheroedge

- Pathway: 510(k) (Traditional)
- Applicant: Atheropoint, LLC
- Decided: Sep 26, 2012 after 78 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: 3 generations back to K021966 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030223: Sonocalc, Sonometric Health, LLC (2003) Summary page 1.
- K043360: Imt.Lab, Pie Medical (2005) Summary page 1.

## Most influential descendants
- K201369: AVA (Augmented Vascular Analysis) (2020), 0 descendants of its own

## Indications for use
The AtheroEdge' software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.

Source page: https://510kreport.com/device/K122022
Methodology: https://510kreport.com/methodology