# K023970: Quantitative Vascular Angiography - CMS

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Jan 24, 2003 after 56 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940172 (1994). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993763: Quantitative Analysis of Coronary Angiograms (Qca), Medis Medical Imaging Systems BV (1999) Summary page 1.

## Most influential descendants
- K112807: X-Ray Vva (2012), 2 descendants of its own
- K034059: Sectra Angiography Package and Sectra Cardiology Package (2004), 2 descendants of its own
- K222036: MPXA-2000 (2023), 1 descendant of its own
- K042781: Ipacs Cardio (2004), 1 descendant of its own
- K252634: Imagine® Enterprise Suite (2026), 0 descendants of its own

## Indications for use
QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.

Source page: https://510kreport.com/device/K023970
Methodology: https://510kreport.com/methodology