# K162793: RHYTHMIA HDx Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 10, 2017 after 157 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: 12 generations back to K001437 (2000). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132782: CARTO3 EP Navigation System, Version 3.2, Biosense Webster, Inc. (2014) Summary page 4.
- K130750: Rhythmia Mapping System, Rhythmia Medical, Inc. (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K162793
Methodology: https://510kreport.com/methodology