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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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RamSoft - B359GWY6PRU90

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

RamSoft - B359GWY6PRU80

RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.8.8111
In Commercial Distribution

  • B359GWY6PRU80 ()


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

RamSoft - B359GWY6PRU720

RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359GWY6PRU720 ()


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

RamSoft - B359GWY6PRU70

RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359GWY6PRU70 ()
GWY6PRU7

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

RamSoft - B359GWR6PRU90

RamSoft Gateway Router 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359GWR6PRU90 ()


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

RamSoft - B359GWR6PRU720

RamSoft Gateway Router 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359GWR6PRU720 ()


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

RamSoft - B359GWR6PRU60

RamSoft Gateway Router 6
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359GWR6PRU60 ()


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

RamSoft - B359GWR6PRU100

RamSoft Gateway Router 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359GWR6PRU100 ()


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

Clear Guide CORE - B201CGCORE24MR0

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer

Clear Guide CORE - B201CGCORE240

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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