RHYTHMIA HDx Mapping System (Software Version 2.0)
510(k) K173837
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173837 | Date25 Jul 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- RHYTHMIA HDx Mapping System (with software Version 2.0)
- 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, 1 Oct 2026
The Rhythmia HDx Mapping System is an electroanatomical mapping device designed for catheter-based mapping of cardiac chambers, including the atria and ventricles. It provides real-time visualization of intracardiac catheters and generates detailed cardiac maps in multiple formats to aid in arrhythmia diagnosis and ablation procedures. This system integrates high-density mapping technology to enhance spatial resolution and precision during electrophysiological studies.
The device is supplied with proprietary software (Version 2.0) and is intended for use in electrophysiology laboratories by trained clinicians. It is classified under product code DQK as a computer-assisted diagnostic device and has received FDA 510(k) clearance under the Traditional pathway. The system is not described as single-use or reusable in the submitted data, and no specific sterility or MRI safety information is provided. Storage and handling instructions are not detailed in the regulatory filing.
Other devices from Boston Scientific
Questions
AI-generated answers, 1 Oct 2026
What is the Rhythmia HDx Mapping System (Version 2.0) used for?
The Rhythmia HDx Mapping System (Version 2.0) is designed for catheter-based electroanatomical mapping of cardiac chambers, including the atria and ventricles. It provides real-time visualization of intracardiac catheters and generates detailed 3D cardiac maps to assist in diagnosing arrhythmias and guiding ablation procedures. The high-density mapping technology improves spatial resolution, helping clinicians achieve more precise electrophysiological studies.
How is the Rhythmia HDx Mapping System supplied, and who can use it?
The system is supplied with proprietary software (Version 2.0) and is intended exclusively for use in electrophysiology laboratories. It is intended for trained clinicians who perform cardiac mapping and ablation procedures. The device integrates hardware and software to enable advanced mapping capabilities, but specific details on supply packaging or additional accessories are not provided in the regulatory data.
Is the Rhythmia HDx Mapping System single-use or reusable?
The regulatory filing does not explicitly state whether the Rhythmia HDx Mapping System is single-use or reusable. This distinction is important for determining handling, sterilization, and disposal protocols. Users should refer to the manufacturer’s instructions for proper use and maintenance based on their specific clinical workflow.
What storage or handling instructions apply to the Rhythmia HDx Mapping System?
The regulatory submission does not include detailed storage or handling instructions for the Rhythmia HDx Mapping System. Proper storage conditions are critical for maintaining device performance and ensuring patient safety. Clinicians should consult the manufacturer’s official documentation or contact Boston Scientific for guidance on storage environments, temperature controls, and shelf-life considerations.
Is the Rhythmia HDx Mapping System compatible with MRI environments?
The regulatory filing does not provide explicit information regarding the MRI safety of the Rhythmia HDx Mapping System. If MRI compatibility is a concern, clinicians should verify this with Boston Scientific or refer to the device’s labeling and safety documentation to avoid potential risks during imaging procedures.