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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
Alpinion Medical Systems Co., Ltd.
E-CUBE inno
In Commercial Distribution

  • 08800013527004 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE i7
In Commercial Distribution

  • 08800013526007 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 15
In Commercial Distribution

  • 08800013525000 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 12
In Commercial Distribution

  • 08800013524003 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 11
In Commercial Distribution

  • 08800013523006 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 9
In Commercial Distribution

  • 08800013522009 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 7
In Commercial Distribution

  • 08800013521002 ()


  • General-purpose ultrasound imaging system
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 5
In Commercial Distribution

  • 08800013520005 ()


  • General-purpose ultrasound imaging system
The X-CUBE 60 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 60 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 60
In Commercial Distribution

  • 08800013545008 ()


  • General-purpose ultrasound imaging system
Compact PERINE Probe. 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 application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system
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
KURO-3000-3
In Commercial Distribution

  • 03665134000691 ()
  • 03665134000684 ()
  • 03665134000707 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system
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 application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system
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
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
SonixONE Ultrasound System
ANALOGIC CORPORATION
24.000.100
Not in Commercial Distribution

  • 08294362400024 ()


  • General-purpose ultrasound imaging system
SonixTABLET Ultrasound System
ANALOGIC CORPORATION
24.000.000
Not in Commercial Distribution

  • 08294362400000 ()


  • General-purpose ultrasound imaging system
SonixSP Q+Ultrasound System
ANALOGIC CORPORATION
22.000.000-02
Not in Commercial Distribution

  • 08294362200020 ()


  • General-purpose ultrasound imaging system
SonixSP Ultrasound System
ANALOGIC CORPORATION
22.000.000
Not in Commercial Distribution

  • 08294362200006 ()


  • General-purpose ultrasound imaging system
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