# K092842: Echoplaque

- Pathway: 510(k) (Traditional)
- Applicant: Indec Systems, Inc.
- Decided: Mar 1, 2010 after 167 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: 5 generations back to K941322 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021495: QIVA, Pie Medical Imaging BV (2002) Summary page 1.
- K011582: Qcu Analytical Software Package, Medis Medical Imaging Systems BV (2001)

## Most influential descendants
- K123970: Caas Intravascular (2013), 1 descendant of its own
- K210931: Libby IAAA v1.0 (2021), 0 descendants of its own

## Indications for use
echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPiaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.

Source page: https://510kreport.com/device/K092842
Methodology: https://510kreport.com/methodology