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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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Ultrasound system, imaging, general-purpose, portable
TELEMED UAB
EXT-1M
In Commercial Distribution

  • 04772057000154 ()


  • General-purpose ultrasound imaging system
Ultrasound system, imaging, general-purpose, portable
TELEMED UAB
EXT-1H
In Commercial Distribution

  • 04772057000109 ()


  • General-purpose ultrasound imaging system
I-STREME ECHO ULTRASOUND SYSTEM with Linear Array Probe
INTERSON CORP
1
In Commercial Distribution

  • 00850921007219 ()


  • General-purpose ultrasound imaging system
ZS3 - SP Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3-SP
Not in Commercial Distribution

  • 00851315007211 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
Z.One PRO
Not in Commercial Distribution

  • 00851315007013 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3
Not in Commercial Distribution

  • 00851315007006 ()


  • General-purpose ultrasound imaging system
The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. It includes the following scanning modes: B, B+M, B+D, B+C, B+D+C . (D is PWD, C is Color Flow mapping Doppler including Velocity and Variance display, Amplitude(power)Doppler including directional display ). B mode includes Tissue Harmonic Imaging , VFI (Vector Flow Imaging), Elastography, Contrast Imaging, CW doppler. The system performs simple geometric measurements and calculations in the following areas: Urology, Vascular, Cardiology, OB/GYN, Emergency Medicine, Surgery, and Anesthesia. Optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Bk Medical ApS
1300
In Commercial Distribution

  • 05704916001285 ()
1300

  • General-purpose ultrasound imaging system
Mobile Touch Dock with battery. Includes Power Cable Holder
Bk Medical ApS
UA1814
Not in Commercial Distribution

  • 05704916001087 ()


  • General-purpose ultrasound imaging system
Mobile Touch Dock with backpack
Bk Medical ApS
UA1810
Not in Commercial Distribution

  • 05704916001070 ()


  • General-purpose ultrasound imaging system
Keyboard Table Dock
Bk Medical ApS
UA1283
Not in Commercial Distribution

  • 05704916001063 ()


  • General-purpose ultrasound imaging system
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