ALPINION MEDICAL SYSTEMS CO.,LTD

Address:4F, 15, Magokjungang 14-ro,Gangseo-gu Seoul,KR

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Device Description : The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE 70 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 70 is intended to be used in a hospital or medical clinic.

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The X-CUBE 90 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE 90 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 90 is intended to be used in a hospital or medical clinic.

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the ord The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who isqualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; SmallOrgan(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 i8 is intended to be used in a hospital or medical clinic.

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The X-CUBE i9 diagnostic ultrasound system is intended for use by, or by the ord 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 isqualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; SmallOrgan(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.

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1