Cleared Traditional

RHYTHMIA HDx? Mapping System

K241227 · Boston Scientific Corporation · Cardiovascular
Aug 2024
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K241227 is an FDA 510(k) clearance for the RHYTHMIA HDx? Mapping System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Boston Scientific Corporation (St. Paul, US). The FDA issued a Cleared decision on August 29, 2024, 119 days after receiving the submission on May 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K241227 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2024
Decision Date August 29, 2024
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

Similar Devices — DQK Computer, Diagnostic, Programmable

All 423
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO? 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar? Mapping System
K252164 · Imricor Medical Systems · Jan 2026