X-CUBE i8 - The X-CUBE i8 diagnostic ultrasound system is - ALPINION MEDICAL SYSTEMS CO.,LTD

Duns Number:557800655

Device Description: The X-CUBE i8 diagnostic ultrasound system is intended for use by, or by the order of, and 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.

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More Product Details

Catalog Number

-

Brand Name

X-CUBE i8

Version/Model Number

X-CUBE i8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213523

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

d0385f77-0019-410d-b232-b67b795f5059

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPINION MEDICAL SYSTEMS CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84