X-CUBE 60

GUDID 08800013545008

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.

General-purpose ultrasound imaging system

• Primary Device ID: 08800013545008
• NIH Device Record Key: 62a78aa5-22db-40ed-9f51-98467424ebec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CUBE 60
• Version Model Number: X-CUBE 60
• 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	08800013545008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220857

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-16
• Device Publish Date: 2022-11-01

Devices Manufactured by Alpinion Medical Systems Co., Ltd.

• 08800013510006 - L3-12: 2022-11-16
• 08800013510013 - L3-12H: 2022-11-16
• 08800013510020 - L3-8: 2022-11-16
• 08800013510044 - L3-12i: 2022-11-16
• 08800013510051 - L3-8i: 2022-11-16
• 08800013510068 - L8-17X: 2022-11-16
• 08800013510082 - L8-17i: 2022-11-16
• 08800013510099 - IO3-12: 2022-11-16