# K021495: QIVA

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Oct 1, 2002 after 145 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941322 (1995). 4 ancestors in all.
3 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)
- K011582: Qcu Analytical Software Package, Medis Medical Imaging Systems BV (2001)

## Most influential descendants
- K092842: Echoplaque (2010), 2 descendants of its own
- K123970: Caas Intravascular (2013), 1 descendant of its own
- K210931: Libby IAAA v1.0 (2021), 0 descendants of its own

## Indications for use
1. Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format 2. Quantitative analysis of artery and stent dimensions.

Source page: https://510kreport.com/device/K021495
Methodology: https://510kreport.com/methodology