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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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VISIUSmatrix - 00857534006622

Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution

  • 00857534006622 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006493

Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006363

Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution

  • 00857534006363 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006684

Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution

  • 00857534006684 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006677

Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution

  • 00857534006677 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006660

Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution

  • 00857534006660 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006653

Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution

  • 00857534006653 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006646

Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution

  • 00857534006646 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

Buzz 2.0 - 04056481140977

No Description
Brainlab AG
15800
Not in Commercial Distribution

  • 04056481140977 ()


  • Medical image management system
  • Radiology picture archiving and communication system workstation

Clear Guide Optical Head - B201CGOHM0

The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
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