# K982203: Caas II Lva Biplane Option

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Equipment B.V.
- Decided: Jul 14, 1998 after 22 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 K922804 (1992). 3 ancestors in all.
45 later devices descend from it; 2 cite 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)
- K945460: Philips CD Medical Recorder, View Station, Dup[[Lication Station, Philips Medical Systems North America, Inc. (1995) Summary page 1.
- K925302: Philips Integris H/HM System, Philips Medical Systems, Inc. (1992) Summary page 1.
- K922804: Awos Angiographic Workstation, Siemens Medical Solutions USA, Inc. (1992) Summary page 1.

## Most influential descendants
- K033920: Caas II Rva (2004), 44 descendants of its own
- 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

## Indications for use
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 ventricular volumes - calculation of derived parameters; Quantification of the motion of the ventricular wall by applying several established models - Estimation of the dimensions of the myocardiac wall.

Source page: https://510kreport.com/device/K982203
Methodology: https://510kreport.com/methodology