# K973751: MT-200

- Pathway: 510(k) (Traditional)
- Applicant: Schiller America, Inc.
- Decided: Aug 25, 1998 after 328 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: 1 generation back to K914577 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914577: Rhythmscan Precision 6000, Precision Health Care Systems, Inc. (1992) Summary page 1.

## Indications for use
The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for. the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG.recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass .operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

Source page: https://510kreport.com/device/K973751
Methodology: https://510kreport.com/methodology