X-CUBE i8

GUDID 08800013542007

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 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 i8 is intended to be used in a hospital or medical clinic.

ALPINION MEDICAL SYSTEMS CO.,LTD

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 08800013542007
• NIH Device Record Key: d0385f77-0019-410d-b232-b67b795f5059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CUBE i8
• Version Model Number: X-CUBE i8
• Company DUNS: 557800655
• Company Name: ALPINION MEDICAL SYSTEMS CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800013542007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213523

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-14
• Device Publish Date: 2022-02-05

Devices Manufactured by ALPINION MEDICAL SYSTEMS CO.,LTD

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• 08800013510075 - L3-12X: 2022-11-02
• 08800013510150 - L3-8H: 2022-11-02
• 08800013512093 - P1-5CT: 2022-11-02
• 08800013513076 - EC3-10T: 2022-11-02
• 08800013513083 - EV3-10T: 2022-11-02
• 08800013515001 - VE3-10H: 2022-11-02
• 08800013519016 - CW5.0: 2022-11-02