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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100~240V~ 120kV
DRGEM Corporation
JADE-32
In Commercial Distribution

  • 08800011150082 ()


  • Mobile basic diagnostic x-ray system, analogue
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
Accuray Precision™ Treatment Planning System (Version 3.1)
Accuray Incorporated
1070891
In Commercial Distribution

  • 00811376030146 ()
NA

  • Radiation therapy treatment planning workstation
Accuray Precision® Treatment Planning System
Accuray Incorporated
1049210-000
In Commercial Distribution

  • 00811376030221 ()
NA

  • Radiation therapy treatment planning workstation
Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4 DR Virtualized
In Commercial Distribution

  • 00840682152082 ()


  • Nuclear medicine system workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4.1450
In Commercial Distribution

  • 00840682147545 ()


  • Nuclear medicine system workstation
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Viewer
In Commercial Distribution

  • 00840682141109 ()


  • Ultrasound imaging system workstation
ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports.
INTUITIVE IMAGING INFORMATICS, LLC
ImageQube
In Commercial Distribution

  • B688IMAGEQUBE0 ()


  • Radiology picture archiving and communication system workstation
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
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