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RHYTHMIA HDx Mapping System

by Boston Scientific

510(k) K241227

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241227↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241227 Date29 Aug 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DQK
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 870.1425
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RHYTHMIA HDx Mapping System is an electroanatomical mapping device designed for detailed visualization of cardiac electrical activity. It provides high-density, high-resolution mapping of cardiac chambers to assist in the diagnosis and treatment of complex arrhythmias, including atrial and ventricular tachycardias.

This system is intended for use in electrophysiology laboratories and is supplied as a reusable medical device. It includes components such as the IntellaMap Orion mini-basket catheter and automated annotation software. The device is authorized under FDA 510(k) clearance and MDR compliance, with a product code of DQK. Sterility and single-use status are not applicable, as the system requires calibration and maintenance between procedures.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of arrhythmias is the RHYTHMIA HDx Mapping System specifically designed to help diagnose and treat?

    The RHYTHMIA HDx Mapping System is designed to assist in diagnosing and treating complex arrhythmias, particularly atrial and ventricular tachycardias. Its high-density, high-resolution mapping capabilities provide detailed visualization of cardiac electrical activity, which helps electrophysiologists identify abnormal pathways and guide precise interventions during procedures in an electrophysiology lab.

  • Is the RHYTHMIA HDx Mapping System reusable, and if so, what maintenance does it require?

    Yes, the RHYTHMIA HDx Mapping System is a reusable medical device. Since it requires calibration and maintenance between procedures, it is not intended for single-use. Proper upkeep ensures accurate mapping and reliable performance for subsequent electrophysiological studies, making it suitable for repeated use in clinical settings.

  • What key components are included in the RHYTHMIA HDx Mapping System, and how do they contribute to its functionality?

    The system includes the IntellaMap Orion mini-basket catheter, which enables detailed mapping of cardiac chambers, and automated annotation software that processes and visualizes electrical activity data. Together, these components allow clinicians to create precise 3D maps of arrhythmic activity, aiding in targeted ablation or other therapeutic interventions during electrophysiology procedures.

  • How is the RHYTHMIA HDx Mapping System regulated, and what does that mean for its use in clinical settings?

    The RHYTHMIA HDx Mapping System holds both FDA 510(k) clearance and MDR compliance, indicating it has undergone regulatory review to demonstrate substantial equivalence to existing devices. This means it is authorized for use in electrophysiology labs under established safety and performance standards, ensuring clinicians can rely on its accuracy and reliability for complex arrhythmia cases.