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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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Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
IMPEDIMED LIMITED
V 5.0.0
In Commercial Distribution

  • B277SFT0250 ()
SFT-025

  • Bioelectrical body composition analyser
No Description
General Sleep
Insight/Insight+
In Commercial Distribution

  • B5662000010 ()


  • Electroencephalographic monitoring system
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359PSPACS60 ()
PSPACS6

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSGWY6PRU11B0 ()
PSGWY6PRU11B

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution

  • B359PSGWY6PRU11A0 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWY6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWR6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
OmegaAI Image Viewer
Ramsoft Inc
1.0
In Commercial Distribution

  • B359OAIIV11 ()
OAIIV1

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.9.9061
In Commercial Distribution

  • B359GWY6PRU9GA0 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359GWY6PRU90 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
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