Rhythmia HDxTM Mapping System
510(k) K192438
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK192438 | Date27 Nov 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 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
The Rhythmia HDx Mapping System is an electrophysiological (EP) device classified as a 3D Cardiac Mapping and Navigation System (FDA Product Code: DQK). It provides ultra-high-definition mapping of cardiac electrical activity to assist in diagnosing and treating arrhythmias by visualizing detailed anatomical and electrophysiological data in three dimensions.
This system is used in electrophysiological laboratories for real-time 3D mapping and navigation during cardiac procedures. It employs continuous signal acquisition and advanced algorithms to generate high-resolution maps of cardiac chambers, aiding in catheter ablation and arrhythmia characterization. Supplied as a reusable medical device, it requires adherence to sterile techniques and proper calibration. Authorized under FDA 510(k) clearance (K192438) and MDR, it is intended for use in regulated clinical settings.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
What types of cardiac procedures is the Rhythmia HDx™ Mapping System designed to assist with in real-time?
The Rhythmia HDx™ Mapping System is specifically designed to assist in electrophysiological (EP) laboratory procedures, particularly for catheter ablation and arrhythmia characterization. It provides ultra-high-definition 3D mapping of cardiac electrical activity, enabling precise visualization of anatomical and electrophysiological data to guide interventions like ablation therapy for irregular heart rhythms.
Is the Rhythmia HDx™ Mapping System intended for single-use or can it be reused in multiple procedures?
The Rhythmia HDx™ Mapping System is classified as a reusable medical device. While the core system itself is not disposable, it must be handled with sterile techniques during use to ensure patient safety, and it requires proper calibration between procedures to maintain accuracy.
How does the system’s 3D mapping technology improve accuracy compared to traditional methods?
The Rhythmia HDx™ Mapping System uses continuous signal acquisition and advanced algorithms to generate high-resolution 3D maps of cardiac chambers. This provides real-time, ultra-detailed anatomical and electrophysiological data, allowing clinicians to visualize arrhythmogenic substrates with greater precision than traditional 2D or lower-resolution mapping techniques, ultimately improving ablation targeting and procedural outcomes.
What regulatory pathways does the Rhythmia HDx™ Mapping System follow, and which advisory committee was involved?
The Rhythmia HDx™ Mapping System was cleared through the FDA 510(k) pathway under Traditional Review, with a decision classified as Substantially Equivalent (SESE). The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the product code DQK (3D Cardiac Mapping and Navigation System). It is also authorized under the EU MDR (Medical Device Regulation).