# K130750: Rhythmia Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmia Medical, Inc.
- Decided: Jul 22, 2013 after 125 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: 6 generations back to K001437 (2000). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01), Biosense Webster, Inc. (2007) Summary page 2.
- K070902: Modification to: Ensite System, Model, EE3000, St Jude Medical (2007) Summary page 2.

## Most influential descendants
- K162793: RHYTHMIA HDx Mapping System (2017), 3 descendants of its own
- K173837: RHYTHMIA HDx Mapping System (with software Version 2.0) (2018), 2 descendants of its own
- K192438: Rhythmia HDxTM Mapping System (2019), 1 descendant of its own
- K241227: RHYTHMIA HDx™ Mapping System (2024), 0 descendants of its own

## Indications for use
The Rhythmia Mapping System and accessories are indicated for catheter based atrial and ventricular mapping. The mapping system allows real-time visualization of intra-cardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intra-cardiac electrograms, may also be recorded and displayed on the system's display screen.

Source page: https://510kreport.com/device/K130750
Methodology: https://510kreport.com/methodology