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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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72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, LARGE
In Commercial Distribution

  • 15420045513976 ()
ASY-14451

  • Microscope slide digital imaging scanner IVD
  • Laboratory instrument/analyser application software IVD
32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, BASE
In Commercial Distribution

  • 15420045513921 ()
ASY-14305

  • Laboratory instrument/analyser application software IVD
  • Microscope slide digital imaging scanner IVD
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution

  • 07290110252694 ()
HASP-SW-KNH300-1-UP-1

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I2
In Commercial Distribution

  • 07290110252632 ()
HASP-SW-K-I2-01

  • Patient-administration information system application software
  • Cardiopulmonary stress exercise monitoring system computer
  • Cardiovascular risk evaluation interpretive software
Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution

  • M65810604640 ()
NA

  • Linear accelerator system
Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.
TECHNIDATA
TDGenet
In Commercial Distribution

  • 03770027519027 ()


  • Clinical laboratory information system application software
Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.
TOBII DYNAVOX LLC
Indi 7
Not in Commercial Distribution

  • 07340074601042 ()
750518

  • Voice synthesizer/digitizer
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
Roentgen Works 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008247 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
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