# K993765: Quantitative Analysis of Left Ventricular Angiograms (QLV)

- Pathway: 510(k) (Special)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Nov 26, 1999 after 18 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: 1 generation back to K940172 (1994). 1 ancestor in all.
113 later devices descend from it; 4 cite it directly.
5 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940172: Cardiovascular Measurement System-CMS, Medis Medical Imaging Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K994283: Mri- Magnetic Resonance Analytical Software System (2000), 68 descendants of its own
- K073328: Cardiop-B System, Version 2.1 with Lva (2008), 37 descendants of its own
- K082907: IC-Pro System, Version 3.1.0.4 (2008), 36 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools (2008), 28 descendants of its own

## Indications for use
QLV-CMS provides quantitative information regarding the calculated dimensions and calculated performance characteristics of the left ventricle of the heart, imaged during angiographuc x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications: 1. Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies, 2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

Source page: https://510kreport.com/device/K993765
Methodology: https://510kreport.com/methodology