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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 device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
VISION™-V SNAP
In Commercial Distribution

  • 00857088008097 ()
  • 00857088008080 ()
TX-3-3109

  • Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for the purpose of instrument tracking. Component body part # TX-3-3203
TrackX Technology, LLC
VISION-T SNAP
In Commercial Distribution

  • 00857088008066 ()
  • 00857088008042 ()
  • 00857088008059 ()
TX-3-3108

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 12 inch C-Arm
TrackX Technology, LLC
12 inch Source Cap Original Assembly
In Commercial Distribution

  • 00857088008035 ()
TX-3-3148

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the source side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch Source Cap Original Assembly
In Commercial Distribution

  • 00857088008028 ()
TX-3-3091

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch C-Arm Collar Assembly
Not in Commercial Distribution

  • 00857088008011 ()
TX-3-3086

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 12 inch C-Arm
TrackX Technology, LLC
12 inch C-Arm Collar Assembly
Not in Commercial Distribution

  • 00857088008004 ()
TX-3-3142

  • Diagnostic x-ray digital imaging system workstation application software
No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software
Angio Workstation Software
CANON MEDICAL SYSTEMS CORPORATION
XIDF-AWS801
In Commercial Distribution

  • 04987670100451 ()


  • Diagnostic x-ray digital imaging system workstation application software
AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.
AMCAD BIOMED CORPORATION
1.0
In Commercial Distribution

  • 04719875623103 ()
UO-0102

  • Ultrasound imaging system application software
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution

  • 04719875621130 ()
UT-0222-1Q

  • Ultrasound imaging system application software
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