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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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Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system
Radiotherapy quality assurance software tool.
DOSISOFT
2.0.10
In Commercial Distribution

  • B501EPIGRAY020010 ()
EP1001

  • Radiation therapy software
Radiotherapy software quality assurance tool
DOSISOFT
2.0.7
In Commercial Distribution

  • B501EPIGRAY020007 ()
2.0.7

  • Radiation therapy software
Radiotherapy software quality assurance tool.
DOSISOFT
2.0.6
In Commercial Distribution

  • B501EPIGRAY020006 ()
2.0.6

  • Radiation therapy software
Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution

  • B761R51011 ()


  • Radiological PACS software
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI80600 ()


  • Electroencephalographic spectrum analyser
NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Ochs Labs LLC
LW3
In Commercial Distribution

  • G253LW30 ()


  • Biofeedback system application software
Software, Version 1.0.0.4, Treatment Delivery Console, Radixact (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1057727
In Commercial Distribution

  • M65810577270 ()
NA

  • Linear accelerator system
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.2.0
In Commercial Distribution

  • B432360CAS2200 ()


  • Robotic surgical navigation system application software
This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Terarecon Inc.
Cardiac.Chambers.MR01
In Commercial Distribution

  • CARDIACCHAMBERSMR1 ()
CARDIACCHAMBERSMR1

  • Radiology DICOM image processing application software
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