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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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Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000208 ()
ND3

  • Biofeedback system application software
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
No Description
Thought Technology Ltd.
SA7900AR
In Commercial Distribution

  • 07540191000647 ()


  • Biofeedback system application software
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
VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution

  • 03573026555504 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions. cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution

  • 00860006442682 ()


  • Radiology DICOM image processing application software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586356 ()


  • Dental x-ray image interpretive software
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