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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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AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution

  • 05056190500726 ()
AlignRT 7.3 (software)

  • Radiological video camera patient positioning/tracking system
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution

  • D875403051 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution

  • D875400101 ()


  • General-purpose dental x-ray system application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy 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
Omniscient Neurotechnology Pty Ltd (o8t)
2.1
In Commercial Distribution

  • 09358140000055 ()
SCI0006

  • Radiological PACS software
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution

  • 05055272715744 ()


  • Ophthalmic examination slit lamp
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
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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