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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 Class Implantable

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THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.
THD SPA
THD 4K CAM
In Commercial Distribution

  • 18033737712341 ()
800195

  • Ultrasound imaging system application software
Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software
MD EchoPAC Plug-In v210
GE Vingmed Ultrasound AS
Plug-In v210
In Commercial Distribution

  • 00195278951717 ()


  • Ultrasound imaging system application software
MD EchoPAC Software Only v210
GE Vingmed Ultrasound AS
Software Only v210
In Commercial Distribution

  • 00195278951700 ()


  • Ultrasound imaging system application software
Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system
No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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