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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 Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
VIASONIX LTD
Falcon/Xpress
In Commercial Distribution

  • 07290016880533 ()


  • General-purpose ultrasound imaging system
10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements.
VIASONIX LTD
10 MHz probe
Not in Commercial Distribution

  • 07290016880410 ()
PVC0332

  • General-purpose ultrasound imaging system
The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children.The Rimed Transcarial Doppler Systems are based on a PC platform system. As opposed to the currently approved product Digi-Lite TCD that has the PC component in the device itself, the Digi-One TCD uses a LAN cable to connect and act with any external PC operated with Windows 7 and up
RIMED LTD.
Digi-One
In Commercial Distribution

  • 07290016734027 ()


  • General-purpose ultrasound imaging system
The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP.
RIMED LTD.
Digi-Lite IP
In Commercial Distribution

  • 07290016734010 ()
400001

  • General-purpose ultrasound imaging system
The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disc, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15″ TFT color SVGA that provides 1024 × 768 points graphic resolution.
RIMED LTD.
Digi-Lite
In Commercial Distribution

  • 07290016734003 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd.
Evolution XHD 80
In Commercial Distribution

  • 06975170000065 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd.
Evolution XHD 70
In Commercial Distribution

  • 06975170000058 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd.
Evolution XHD 65
In Commercial Distribution

  • 06975170000041 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd.
Evolution XHD 60
In Commercial Distribution

  • 06975170000034 ()


  • General-purpose ultrasound imaging system
Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd.
Evolution XHD 55
In Commercial Distribution

  • 06975170000027 ()


  • General-purpose ultrasound imaging system
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