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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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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
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
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
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
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
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
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution

  • 00851800007078 ()
ExamVue PACS 1.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
Local Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-500
Not in Commercial Distribution

  • 00851551005194 ()


  • Microwave hyperthermia system
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
In Commercial Distribution



  • Microwave hyperthermia system
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Pyrexar Medical Inc.
BSD-500
In Commercial Distribution



  • Microwave hyperthermia system
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