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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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3D End-Fire Endocavity Probe - 03665134000073

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system

TRINITY - 03665134000035

A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO3000-2
Not in Commercial Distribution

  • 03665134000547 ()
  • 03665134000035 ()
  • 03665134000554 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362400024

SonixONE Ultrasound System
ANALOGIC CORPORATION
24.000.100
Not in Commercial Distribution

  • 08294362400024 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362400000

SonixTABLET Ultrasound System
ANALOGIC CORPORATION
24.000.000
Not in Commercial Distribution

  • 08294362400000 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362200020

SonixSP Q+Ultrasound System
ANALOGIC CORPORATION
22.000.000-02
Not in Commercial Distribution

  • 08294362200020 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362200006

SonixSP Ultrasound System
ANALOGIC CORPORATION
22.000.000
Not in Commercial Distribution

  • 08294362200006 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362100023

SonixOP Q+ Ultrasound System
ANALOGIC CORPORATION
21.000.000-02
Not in Commercial Distribution

  • 08294362100023 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362100009

SonixOP Ultrasound System
ANALOGIC CORPORATION
21.000.000
Not in Commercial Distribution

  • 08294362100009 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362000026

SonixMDP Q+ Ultrasound System
ANALOGIC CORPORATION
20.000.000-02
Not in Commercial Distribution

  • 08294362000026 ()


  • General-purpose ultrasound imaging system

Ultrasonix Medical Corporation - 08294362000002

SonixMDP Ultrasound System
ANALOGIC CORPORATION
20.000.000
Not in Commercial Distribution

  • 08294362000002 ()


  • General-purpose ultrasound imaging system
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