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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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Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution

  • 00860002545714 ()


  • Ultrasound imaging system application software
No Description
GE Healthcare Finland Oy
E-ENTROPY-01
In Commercial Distribution

  • 00840682104272 ()


  • Patient monitoring system module, electroencephalographic
IP Alarm Relay Box accessory kit
XLTEK
024006
In Commercial Distribution

  • 00382830058575 ()


  • Electroencephalograph
Patient Room Alarm Relay Box (IP Version)
XLTEK
023019
In Commercial Distribution

  • 00382830058216 ()


  • Electroencephalograph
IP Alarm Controller, Box
XLTEK
022979
In Commercial Distribution

  • 00382830058209 ()


  • Electroencephalograph
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical
No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution

  • 00860475000383 ()


  • Wound management image-analysis software
Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution

  • 05706069659788 ()
8 393 0101 112

  • Hearing aid remote control application software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272716 ()


  • Wound management image-analysis software
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