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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 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

Merge Cardio - 00842000100065

No Description
MERGE HEALTHCARE SOLUTIONS INC.
12.2
In Commercial Distribution

  • 00842000100065 ()


  • Radiology picture archiving and communication system workstation

Xeleris Processing and Review System - 00840682152082

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4 DR Virtualized
In Commercial Distribution

  • 00840682152082 ()


  • Nuclear medicine system workstation

Xeleris Processing and Review Workstation - 00840682147545

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4.1450
In Commercial Distribution

  • 00840682147545 ()


  • Nuclear medicine system workstation

Invenia - 00840682141109

No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Viewer
In Commercial Distribution

  • 00840682141109 ()


  • Ultrasound imaging system workstation

Avatar Medical Software V1 - 03770026095003

AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
AVATAR MEDICAL
AMS V1
Not in Commercial Distribution

  • 03770026095003 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7410

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Convergent Imaging Solutions Incorporated
7-4-1-PX
In Commercial Distribution

  • B843UNISYN7410 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7340

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-4-PX
In Commercial Distribution

  • B843UNISYN7340 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7330

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-3-PX
In Commercial Distribution

  • B843UNISYN7330 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7320

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-2-PX
In Commercial Distribution

  • B843UNISYN7320 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7310

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-1-PX
Not in Commercial Distribution

  • B843UNISYN7310 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7210

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-2-1-PX
Not in Commercial Distribution

  • B843UNISYN7210 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN7110

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-1-1-PX
Not in Commercial Distribution

  • B843UNISYN7110 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6260

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-6-PX
Not in Commercial Distribution

  • B843UNISYN6260 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6250

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-5-PX
Not in Commercial Distribution

  • B843UNISYN6250 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6240

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-4-PX
Not in Commercial Distribution

  • B843UNISYN6240 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6230

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-3-PX
Not in Commercial Distribution

  • B843UNISYN6230 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6220

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-2-PX
Not in Commercial Distribution

  • B843UNISYN6220 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6210

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-1-PX
Not in Commercial Distribution

  • B843UNISYN6210 ()


  • Radiology picture archiving and communication system workstation

UniSyn - B843UNISYN6110

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-1-1-PX
Not in Commercial Distribution

  • B843UNISYN6110 ()


  • Radiology picture archiving and communication system workstation
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