# K112807: X-Ray Vva

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Feb 27, 2012 after 153 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: 4 generations back to K896095 (1990). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 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.
- K993765: Quantitative Analysis of Left Ventricular Angiograms (QLV), Medis Medical Imaging Systems BV (1999) Summary page 1.
- K023970: Quantitative Vascular Angiography - CMS, Medis Medical Imaging Systems BV (2003) Summary page 1.
- K993761: Cardiovascular Measurement System - View, Medis Medical Imaging Systems BV (1999) Summary page 1.
- K052988: CAAS, Pie Medical Imaging BV (2005) Summary page 1.

## Most influential descendants
- K222036: MPXA-2000 (2023), 1 descendant of its own
- K252634: Imagine® Enterprise Suite (2026), 0 descendants of its own

## Indications for use
X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by X-RAY VVA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K112807
Methodology: https://510kreport.com/methodology