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Merge Healthcare Incorporated

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21839261000116130Merge Healthcare Incorporated1Y2026-01-01900 Walnut Ridge Dr Hartland WI US 53029

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
803941095969671K913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMHKI1991-11-27
803941570073108K250301Merge Universal Viewer (MUV)LLZ2025-04-14
803941539743836K233326Merge Hemo, Model RCSV2DQK2024-06-21
803941019195841K203104IBM iConnect AccessLLZ2021-01-26
803941741531599K192455Merge PACSLLZ2019-10-17
803941807073152K192276Merge CardioLLZ2019-09-20
803941720641010K182290IBM iConnect AccessLLZ2018-09-25
803941788413433K173475Merge PACSLLZ2017-12-08
803941510501176K152864Merge HemoDQK2016-04-07
803941071932922K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEMNFJ2011-05-18
803941379796486K092954CADSTREAM VERSION 5LLZ2009-11-06
803941752053600K092915CEDARA WEBACCESS, MODEL: 2.4LLZ2010-06-23
803941909284535K082421HEARTSUITE HEMODYNAMICS 7.10DQK2008-12-17
803941890464754K082144AMICAS PACS, VERSION 6.0LLZ2008-09-05
803941555549161K053281EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)LLZ2005-12-07
803941801870079K051649VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0LLZ2005-08-02
803941847595266K041935DR SYSTEMS PACS, RELEASE 6.1LLZ2004-08-16
803941070820625K022881CEDARA I-SOFTVIEWLLZ2002-10-22
803942068667053K020995EFILM WORKSTATION WITH MODULESLLZ2002-04-12
803941945781992K012211EFILM WORKSTATIONLLZ2001-07-31
803941355444258

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ152025-04-14
DQK32024-06-21
NFJ12011-05-18
HKI11991-11-27

PMN#

GUDID#

Merge Cardio - Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

MERGE HEALTHCARE SOLUTIONS INC.

2024-02-05

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