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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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SonixSP Ultrasound System
ANALOGIC CORPORATION
22.000.000
Not in Commercial Distribution

  • 08294362200006 ()


  • General-purpose ultrasound imaging system
SonixOP Q+ Ultrasound System
ANALOGIC CORPORATION
21.000.000-02
Not in Commercial Distribution

  • 08294362100023 ()


  • General-purpose ultrasound imaging system
SonixOP Ultrasound System
ANALOGIC CORPORATION
21.000.000
Not in Commercial Distribution

  • 08294362100009 ()


  • General-purpose ultrasound imaging system
SonixMDP Q+ Ultrasound System
ANALOGIC CORPORATION
20.000.000-02
Not in Commercial Distribution

  • 08294362000026 ()


  • General-purpose ultrasound imaging system
SonixMDP Ultrasound System
ANALOGIC CORPORATION
20.000.000
Not in Commercial Distribution

  • 08294362000002 ()


  • General-purpose ultrasound imaging system
SonixTOUCH Q+ Ultrasound System
ANALOGIC CORPORATION
18.000.000-02
Not in Commercial Distribution

  • 08294361800023 ()


  • General-purpose ultrasound imaging system
SonixTOUCH Ultrasound System
ANALOGIC CORPORATION
18.000.000
Not in Commercial Distribution

  • 08294361800009 ()


  • General-purpose ultrasound imaging system
SonixONE Cart
ANALOGIC CORPORATION
00.024.634
Not in Commercial Distribution

  • 08294360246341 ()


  • 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
The X-CUBE 50 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 50 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE 50
In Commercial Distribution

  • 08800013544001 ()


  • General-purpose ultrasound imaging system
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