# K974679: The TCS-Medcon's Telecardiology System

- Pathway: 510(k) (Traditional)
- Applicant: Medcon, Ltd.
- Decided: Mar 23, 1998 after 98 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: 2 generations back to K942264 (1994). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964274: Writestar, and Viewstar, Comview Corp. (1997) Summary page 1.

## Most influential descendants
- K112720: Mckesson Horizon Cardiology (2012), 3 descendants of its own
- K151850: McKesson Cardiology (2015), 2 descendants of its own
- K181080: McKesson Cardiology (2018), 1 descendant of its own
- K212528: Change Healthcare Cardiology (2021), 0 descendants of its own

## Indications for use
TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.

Source page: https://510kreport.com/device/K974679
Methodology: https://510kreport.com/methodology