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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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US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
NIDEK CO.,LTD.
NAVIS-EX
In Commercial Distribution

  • 04987669100523 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
No Description
CANON MEDICAL SYSTEMS CORPORATION
VSTP-002A
In Commercial Distribution

  • 04987670105005 ()


  • Radiological PACS software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution

  • 05055272715744 ()


  • Ophthalmic examination slit lamp
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.7
In Commercial Distribution

  • 00850005944508 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution

  • 00850005944355 ()
83-00093-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution

  • 00850005944119 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution

  • 00850005944089 ()
83-00054-000

  • Magnetic neural stimulation system
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
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