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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 RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
Terumo Cardiovascular Systems Corporation
802113
In Commercial Distribution

  • 00886799000731 ()
802113

  • Cardiopulmonary bypass system, roller type
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
No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Heart Failure 1.0
In Commercial Distribution

  • 05060634690041 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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
IP Converter
SONY CORPORATION
NU-IP3R
In Commercial Distribution

  • 04548736101920 ()


  • Operating room audiovisual data/device management system
IP Converter
SONY CORPORATION
NU-IP3T
In Commercial Distribution

  • 04548736101913 ()


  • 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
IP Converter (DVI Optical)
SONY CORPORATION
NU-IP40D
In Commercial Distribution

  • 04548736039247 ()


  • 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
IP Converter (SDI Optical)
SONY CORPORATION
NU-IP40S
In Commercial Distribution

  • 04548736033917 ()


  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 ENCODER HD
Barco NV
MNA-420
In Commercial Distribution

  • 05415334053670 ()
600306027

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 DECODER
Barco NV
MNA-240
In Commercial Distribution

  • 05415334053663 ()
600301482

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 ANALOG ENCODER
Barco NV
MNA-120
In Commercial Distribution

  • 05415334053472 ()
600301481

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 ENCODER 4K
Barco NV
MNA-440
In Commercial Distribution

  • 05415334053458 ()
600301479

  • Operating room audiovisual data/device management system
MNA-420 DEC HDMI V2
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050839 ()
K9303331CMS

  • Operating room audiovisual data/device management system
MNA-440 DEC HDMI V2
Barco NV
MNA-440
In Commercial Distribution

  • 05415334050822 ()
K9303311CMS

  • Operating room audiovisual data/device management system
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