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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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SOZOapplication - B277SOZOAPP0

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

  • B277SOZOAPP0 ()


  • Bioelectrical body composition analyser

MYSOZO.com - B277SFT0250

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

QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 - M52516790000

No Description
HELENA LABORATORIES CORPORATION
1679000
In Commercial Distribution

  • M52516790000 ()


  • Densitometry analyser IVD

Zmachine - B5662000010

No Description
General Sleep
Insight/Insight+
In Commercial Distribution

  • B5662000010 ()


  • Electroencephalographic monitoring system

RamSoft - B359PSPACS6PRU110

RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSPACS6PRU110 ()


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

RamSoft - B359PSGWY6PRU11B0

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 - B359PSGWY6PRU11A0

RamSoft Gateway
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution

  • B359PSGWY6PRU11A0 ()


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

RamSoft - B359PSGWY6PRU110

RamSoft Gateway 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWY6PRU110 ()


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

RamSoft - B359PSGWR6PRU110

RamSoft Gateway Router 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWR6PRU110 ()


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

RamSoft - B359OAIIV11

OmegaAI Image Viewer
Ramsoft Inc
1.0
In Commercial Distribution

  • B359OAIIV11 ()
OAIIV1

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