# K990058: QMS Mapping System,Model 2000

- Pathway: 510(k) (Traditional)
- Applicant: Cathdata, Inc.
- Decided: Dec 15, 1999 after 342 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 K902716 (1990). 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)
- K902716: PE Electrophysiology Lab System (Peep), Prucka Engineering, Inc. (1990) Summary page 2.

## Indications for use
The QMS 3000 ™ is indicated for use in the storage, display, retrieval and measurement of ECG signals obtained from intracardiac catheters.

Source page: https://510kreport.com/device/K990058
Methodology: https://510kreport.com/methodology