# K241227: RHYTHMIA HDx™ Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 29, 2024 after 119 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: 15 generations back to K001437 (2000). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192438: Rhythmia HDxTM Mapping System, Boston Scientific Corporation (2019) Summary page 5.
- K162793: RHYTHMIA HDx Mapping System, Boston Scientific Corporation (2017) Summary page 5.

## 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/K241227
Methodology: https://510kreport.com/methodology