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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. The INSIGHT™-6 SNAP is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™-6 SNAP
In Commercial Distribution

  • 00857088008134 ()
  • 00857088008141 ()
200-3TX

  • Diagnostic x-ray digital imaging system workstation application software
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™- I SNAP
Not in Commercial Distribution

  • 00857088008103 ()
TX-3-3110

  • Diagnostic x-ray digital imaging system workstation application software
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
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
No Description
Novadaq Technologies Inc
SQ3500
In Commercial Distribution

  • 00858701006018 ()


  • Angiographic x-ray system application software
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