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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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No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software
No Description
SRS Medical Systems, Inc.
900-026
In Commercial Distribution

  • 00890477000180 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-037
In Commercial Distribution

  • 00890477000098 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
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
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286018 ()


  • Operating room audiovisual data/device management system
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286001 ()


  • Operating room audiovisual data/device management system
MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-4
In Commercial Distribution

  • 04953170391767 ()


  • Operating room audiovisual data/device management system
IP Converter
SONY CORPORATION
NU-IP3R
In Commercial Distribution

  • 04548736101920 ()


  • Operating room audiovisual data/device management system
Network System Manager
SONY CORPORATION
NU-NM11B
In Commercial Distribution

  • 04548736046351 ()


  • Operating room audiovisual data/device management system
Network System Manager
SONY CORPORATION
NU-NM10B
In Commercial Distribution

  • 04548736039230 ()


  • Operating room audiovisual data/device management system
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