Model note · EP Mapping System

Boston Scientific RHYTHMIA HDx Mapping System

Name: Boston Scientific RHYTHMIA HDx Mapping System
Brand: Boston Scientific RHYTHMIA

RHYTHMIA HDx is Boston Scientific's 3D electroanatomical mapping system for atrial and ventricular procedures. It localises catheters with magnetic and impedance technology and builds high density maps, especially with its magnetically tracked mini basket mapping catheter. A Signal Station connects catheters and recording systems and passes data to a Workstation, and recent software adds support for the company's pulsed field ablation catheters.

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The model

Maker, model and type.

Maker: Boston Scientific Corporation
Model: RHYTHMIA HDx Mapping System
Device type: EP Mapping System
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Localisation	Magnetic and impedance based catheter localisation using intracardiac and surface electrograms	Source
Main hardware	Signal Station (SiS) with accessories, plus Workstation computer and software	Source
Map types (original system)	Geometric shell, activation, voltage and fractionation maps	Source
Original Rhythmia mapping catheter	8.5 F, 115 cm, bidirectional basket with 64 electrodes acquiring 64 electrograms at once	Source
Software level of concern	Major, because its output directly drives treatment decisions	Source
Software v6.0 additions	FARAWAVE NAV and FARAPOINT PFA catheter compatibility, sheath visualisation, PACS CT or MRI import, Field Tag, catheter shadows, ablation statistics	Source
Safety standards tested	IEC 60601-1, IEC 60601-2-27, IEC 60601-1-2 and IEC 60601-1-6	Source
FDA clearances	K162793 first HDx clearance (2017), K241227 software v6.0 (2024), product code DQK, 21 CFR 870.1425	Source

Recalls

Recalls.

This note lists no recalls. Check the FDA recall database for the latest record.

Safety

Safety warnings from the record.

The system is for use in an EP laboratory by physicians fully trained in cardiac electrophysiology together with Boston Scientific mapping specialists. Source
Imported CT and MRI images are for visual reference only and must not replace live mapping data. Source

Sources

Where this note comes from.

Not covered: Signal Station channel counts, magnetic field generator details, power data and the system's messages are in the operator's manual, which was not read, so no error codes are given. The 64 electrode catheter figures are for the first Rhythmia catheter; the current INTELLAMAP ORION catheter was not checked. No openFDA recall matched RHYTHMIA. The manufacturerUrl is the Boston Scientific home page and was not opened.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

EP Mapping System