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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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Mircoconvex Probe SMC12-3 Gen II®
Supersonic Imagine, Inc.
SSIP92097
In Commercial Distribution

  • 03760193600070 ()

  • Length: 250 Centimeter
SSIP92097

  • General-purpose ultrasound imaging system
Linear Probe SL10-2 Gen II®
Supersonic Imagine, Inc.
SSIP92085
In Commercial Distribution

  • 03760193600063 ()

  • Length: 250 Centimeter
SSIP92085

  • General-purpose ultrasound imaging system
Endo Probe SE12-3 Gen II®
Supersonic Imagine, Inc.
SSIP92068
In Commercial Distribution

  • 03760193600056 ()

  • Length: 250 Centimeter
SSIP92068

  • General-purpose ultrasound imaging system
AIXPLORER V
Supersonic Imagine, Inc.
SSIP92188
In Commercial Distribution

  • 03760193600049 ()

  • Length: 250 Centimeter
SSIP92188

  • General-purpose ultrasound imaging system
Curved Probe SC6-1 Gen II®
Supersonic Imagine, Inc.
SSIP92030
In Commercial Distribution

  • 03760193600032 ()

  • Length: 250 Centimeter
SSIP92030

  • General-purpose ultrasound imaging system
Linear Probe SL15-4 Gen II®
Supersonic Imagine, Inc.
SSIP92002
In Commercial Distribution

  • 03760193600025 ()

  • Length: 250 Centimeter
SSIP92002

  • General-purpose ultrasound imaging system
Imaging Ultrasound Diagnostic System
Supersonic Imagine, Inc.
SSIP92029
In Commercial Distribution

  • 03760193600018 ()

  • Length: 250 Centimeter
SSIP92029

  • General-purpose ultrasound imaging system
Endocavitary Probe SEV12-3 GEN II
Supersonic Imagine, Inc.
SSIP93189
In Commercial Distribution

  • 03760193600001 ()

  • Length: 250 Centimeter
SSIP93189

  • 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
The X-CUBE i9 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); Trans-esoph. (Cardiac); 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. The X-CUBE i9 is intended to be used in a hospital or medical clinic.
Alpinion Medical Systems Co., Ltd.
X-CUBE i9
In Commercial Distribution

  • 08800013543004 ()


  • General-purpose ultrasound imaging system
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