# K972229: Imageview Coronary Angiography Display and Review System

- Pathway: 510(k) (Traditional)
- Applicant: Heartware, Inc.
- Decided: Oct 16, 1997 after 125 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 K954479 (1996). 2 ancestors in all.
143 later devices descend from it; 1 cites it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954479: Dicomview, Heartlab, Inc. (1996) Summary page 1.
- K960043: Kodak Cardiology Digital Archive & Review System, Jamieson Film Co. (1996) Summary page 1.

## Most influential descendants
- K994210: Inturis Suite (2000), 142 descendants of its own
- K022788: Philips Harmony Release 1 (2002), 129 descendants of its own
- K061995: Xcelera (2006), 128 descendants of its own
- K083348: Image-Arena Applications (2008), 89 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own

## Indications for use
The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

Source page: https://510kreport.com/device/K972229
Methodology: https://510kreport.com/methodology