# K983102: Cardiac Diagnostic System Model CH 2000

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Heart, Inc.
- Decided: Apr 12, 1999 after 221 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K930806 (1994). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981697: Cambridge Heart CH 2000 Cardiac Diagnostic System, Cambridge Heart, Inc. (1998). Cleared while this submission was under review Summary page 1.
- K955015: Zymed Holter Scanner Model 2010, Zymed Medical Instrumentation (1996) Summary page 1.

## Most influential descendants
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (2001), 6 descendants of its own
- K013565: Cardiac Diagnostic System, Model CH2000 (2001), 3 descendants of its own
- K022149: Cardiac Diagnostic System, Model CH2000 (2002), 2 descendants of its own
- K050225: Heartwave II Cardiac Diagnostic System (2005), 1 descendant of its own
- K013615: Micro-Induction 1000 System (2002), 1 descendant of its own

## Indications for use
The CH 2000 is intended for the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.

Source page: https://510kreport.com/device/K983102
Methodology: https://510kreport.com/methodology