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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Merge Cardio - 00842000101123

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.
12.4
In Commercial Distribution

  • 00842000101123 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000101116

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000101116 ()


  • Radiology picture archiving and communication system workstation

Merge Cardio 12.3 - 00842000101109

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.
12.3
In Commercial Distribution

  • 00842000101109 ()


  • Radiology picture archiving and communication system workstation

Merge Universal Viewer - 00842000101093

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.3
In Commercial Distribution

  • 00842000101093 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000101086

No Description
MERGE HEALTHCARE SOLUTIONS INC.
9.0
In Commercial Distribution

  • 00842000101086 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000101031

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.4
In Commercial Distribution

  • 00842000101031 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access - 00842000101024

Correcting entry.
MERGE HEALTHCARE SOLUTIONS INC.
9.0
Not in Commercial Distribution

  • 00842000101024 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access - 00842000101017

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.2
In Commercial Distribution

  • 00842000101017 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access 8.1 - 00842000100980

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.1
In Commercial Distribution

  • 00842000100980 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100935

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.2
In Commercial Distribution

  • 00842000100935 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000100881

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100881 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access - 00842000100843

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100843 ()


  • Radiology picture archiving and communication system workstation

Merge Unity PACS - 00842000100829

No Description
MERGE HEALTHCARE SOLUTIONS INC.
13.0
Not in Commercial Distribution

  • 00842000100829 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100805

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.1
In Commercial Distribution

  • 00842000100805 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access - 00842000100782

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1
In Commercial Distribution

  • 00842000100782 ()


  • Radiology picture archiving and communication system workstation

Merge OrthoPACS - 00842000100775

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.0
In Commercial Distribution

  • 00842000100775 ()


  • Radiology picture archiving and communication system workstation

Merge Cardio - 00842000100768

No Description
MERGE HEALTHCARE SOLUTIONS INC.
12.0.1
In Commercial Distribution

  • 00842000100768 ()


  • Radiology picture archiving and communication system workstation

Merge Cardio V11.1 - 00842000100751

No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.1
In Commercial Distribution

  • 00842000100751 ()


  • Radiology picture archiving and communication system workstation

Merge Unity PACS - 00842000100744

No Description
MERGE HEALTHCARE SOLUTIONS INC.
12.0
In Commercial Distribution

  • 00842000100744 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100737

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.0
In Commercial Distribution

  • 00842000100737 ()


  • Radiology picture archiving and communication system workstation

IBM iConnect Access - 00842000100720

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.0
In Commercial Distribution

  • 00842000100720 ()


  • Radiology picture archiving and communication system workstation

Merge OrthoCase - 00842000100713

No Description
MERGE HEALTHCARE SOLUTIONS INC.
3.7.5
In Commercial Distribution

  • 00842000100713 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100690

Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).
MERGE HEALTHCARE SOLUTIONS INC.
7.3
In Commercial Distribution

  • 00842000100690 ()


  • Radiology picture archiving and communication system workstation

iConnect Access - 00842000100683

Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.5
In Commercial Distribution

  • 00842000100683 ()


  • Radiology picture archiving and communication system workstation

Merge Z3D - 00842000100669

Stand alone software application.
MERGE HEALTHCARE SOLUTIONS INC.
2.0
In Commercial Distribution

  • 00842000100669 ()


  • Radiology picture archiving and communication system workstation

Merge iConnect Access - 00842000100645

Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.
MERGE HEALTHCARE SOLUTIONS INC.
6.4
In Commercial Distribution

  • 00842000100645 ()


  • Radiology picture archiving and communication system workstation

CADstream - 00842000100638

Standalone Software Application
MERGE HEALTHCARE SOLUTIONS INC.
6.2
In Commercial Distribution

  • 00842000100638 ()


  • Radiology picture archiving and communication system workstation

RadSuite - 00842000100614

No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.32
In Commercial Distribution

  • 00842000100614 ()


  • Radiology picture archiving and communication system workstation

Merge Cardio - 00842000100416

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100416 ()


  • Radiology picture archiving and communication system workstation

Merge PACS - 00842000100409

No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100409 ()


  • Radiology picture archiving and communication system workstation
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