# K052988: CAAS

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Dec 30, 2005 after 67 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: 3 generations back to K922804 (1992). 7 ancestors in all.
43 later devices descend from it; 8 cite it directly.
5 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945540: Caas II, Pie Medical Equipment B.V. (1995) Summary page 1.
- K982203: Caas II Lva Biplane Option, Pie Medical Equipment B.V. (1998) Summary page 1.
- K012475: Caas II Qva, Pie Medical Imaging BV (2001) Summary page 1.
- K033920: Caas II Rva, Pie Medical Imaging BV (2004) Summary page 1.

## Most influential descendants
- 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
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own

## Indications for use
CAL Calculate the pixel size of the image to be analyzed MEAS Perform basic length, angle and density measurements. QCA Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment. QVA Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment. LVA biplane Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of left ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall. RVA 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/K052988
Methodology: https://510kreport.com/methodology