Rhythm View Workstation (non-streaming)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System; Impedance Localization Patch Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARING SOLUTION #ECA01976

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUIDED MEDICAL POSITIONING SYSTEM (GMPS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVOXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VX1

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP-STAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

RESPIEVENTS, VERSION 4.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

AI-ECG Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular