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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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Philips FetView - 00884838115958

Submission for Philips FetView version 1.10.0 Initial release
Philips Ultrasound LLC
795268
In Commercial Distribution

  • 00884838115958 ()


  • Radiological PACS software

AQUA - 07340201500101

No Description
Elekta Solutions AB
AQUA 3.2
In Commercial Distribution

  • 07340201500101 ()


  • Radiation therapy software

Aqua - 00858164002381

No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software

OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

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

VISIUSmatrix - 00857534006639

Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution

  • 00857534006639 ()


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