# K011582: Qcu Analytical Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Jul 31, 2001 after 69 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 K941322 (1995). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993394: Echo Scan, Easy Scan, Tomtec Imaging Systems GmbH (1999) Summary page 1.

## Most influential descendants
- K022940: IN-Vision View with Measurements Module, Model 1.0 (2002), 3 descendants of its own
- K021495: QIVA (2002), 3 descendants of its own
- K092842: Echoplaque (2010), 2 descendants of its own
- K123970: Caas Intravascular (2013), 1 descendant of its own
- K041581: Compacs, Version 1.0 (2004), 1 descendant of its own

## Indications for use
QCU has been developed for the objective and reproducible analysis of tomograhic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or atherosclerotic plaque. This information supports the possible placement of intervention devices in these vessels. QCU-CMS enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intra- and inter observer variability. QCU-CMS can be used to control stent placement and to assess in-stent restenosis. QCU software package enables the automatically calculation and the display of various parameters such as: areas and diameters in individual slices: volumes over the segment of interest (Simpson’s Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters. QCU-CMS analytical software is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of ultrasound images. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

Source page: https://510kreport.com/device/K011582
Methodology: https://510kreport.com/methodology