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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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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
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007196 ()


  • General-purpose ultrasound imaging system
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Eko Devices, Inc.
EAS
In Commercial Distribution

  • 00850010298030 ()


  • Cardiopulmonary physiological parameter analysis software
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
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