# K993763: Quantitative Analysis of Coronary Angiograms (Qca)

- 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.
48 later devices descend from it; 5 cite it directly.
5 of 50 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
- K030139: The Cardiop-B System (2004), 40 descendants of its own
- K072591: Cardiop-B System, Version 2.1 (2007), 38 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
- K060483: Volcano Angio-Ivus Mapping (Aim) System (2006), 31 descendants of its own

## Indications for use
QCA-CMS provides quantitative and reproducible information regarding the calculated dimensions of arterial segments imaged during angiographic 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/K993763
Methodology: https://510kreport.com/methodology