# K033920: Caas II Rva

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Mar 17, 2004 after 90 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: 2 generations back to K922804 (1992). 4 ancestors in all.
44 later devices descend from it; 1 cites it directly.
5 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982203: Caas II Lva Biplane Option, Pie Medical Equipment B.V. (1998) Summary page 1.

## Most influential descendants
- K052988: CAAS (2005), 43 descendants of its own
- K063344: Caas Qca 3D (2006), 39 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

## Indications for use
Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of right ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall.

Source page: https://510kreport.com/device/K033920
Methodology: https://510kreport.com/methodology