Shear Wave Quantificational Ultrasound Diagnostic System

GUDID 06971679949942

Wuxi Hisky Medical Technologies Co.,Ltd.

Hepatic ultrasound elastography system

• Primary Device ID: 06971679949942
• NIH Device Record Key: bac870f5-86d5-45c9-b829-5c7f923f46cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shear Wave Quantificational Ultrasound Diagnostic System
• Version Model Number: FH9000
• Company DUNS: 544348534
• Company Name: Wuxi Hisky Medical Technologies Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971679949942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250026

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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[06971679949942]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01

On-Brand Devices [Shear Wave Quantificational Ultrasound Diagnostic System]

• 06971679945005: FT9000
• 06971679949072: Mini800
• 06971679949065: FT100
• 06971679949577: Mini900
• 06971679948990: Mini100
• 06971679948983: Mini300
• 06971679948976: Mini560
• 06971679948969: Mini780
• 06971679948952: Mini790
• 06971679948945: Mini990
• 06971679949997: FH1000
• 06971679949980: FH3000
• 06971679949973: FH5000
• 06971679949966: FH6000
• 06971679949959: FH7000
• 06971679949942: FH9000