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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 TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
MINXRAY, INC.
TR90BH
In Commercial Distribution

  • 00858846007253 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a podiatric mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HFP24 Podiatric X-ray unit
In Commercial Distribution

  • 00858846007246 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors.
MINXRAY, INC.
HFP40 Portable X-ray unit
In Commercial Distribution

  • 00858846007239 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
MINXRAY, INC.
CMDR.TW.1202.R
In Commercial Distribution

  • 00858846007222 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF120/60HPPWV PowerPlus Portable X-ray
In Commercial Distribution

  • 00858846007024 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF100H+ Portable X-ray
In Commercial Distribution

  • 00858846007017 ()


  • Portable basic diagnostic x-ray system, analogue
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors
MINXRAY, INC.
HF1202H Portable X-ray
In Commercial Distribution

  • 00858846007000 ()


  • Portable basic diagnostic x-ray system, analogue
Ultrasound imaging system main unit
Cortex Technology ApS
08
In Commercial Distribution

  • 05710188039000 ()
A0390008

  • Ultrasound imaging system operator console
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution

  • 00852426007022 ()


  • CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution

  • 00852426007015 ()


  • CT system application software
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