# K072591: Cardiop-B System, Version 2.1

- Pathway: 510(k) (Special)
- Applicant: Paieon, Inc.
- Decided: Oct 10, 2007 after 26 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: 5 generations back to K922804 (1992). 12 ancestors in all.
38 later devices descend from it; 1 cites 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)
- K030139: The Cardiop-B System, Paieon, Inc. (2004) Summary page 1.
- K993763: Quantitative Analysis of Coronary Angiograms (Qca), Medis Medical Imaging Systems BV (1999) Summary page 1.
- K063344: Caas Qca 3D, Pie Medical Imaging BV (2006) Summary page 1.

## Most influential descendants
- 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
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own

## Indications for use
The CardiOp-B System is a software system that assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

Source page: https://510kreport.com/device/K072591
Methodology: https://510kreport.com/methodology