Fibrosis Scanning Probe

GUDID 06971679947023

Wuxi Hisky Medical Technologies Co.,Ltd.

Hepatic ultrasound elastography system applicator

• Primary Device ID: 06971679947023
• NIH Device Record Key: 13d8714b-6d1f-4a66-ae7a-01c850b5e95d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibrosis Scanning Probe
• Version Model Number: FT-2.5D9
• Company DUNS: 544348534
• Company Name: Wuxi Hisky Medical Technologies 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8651085387702
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com
• Phone: +8651085387867
• Email: service@hiskymedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971679947023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173595

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: 2020-04-08
• Device Publish Date: 2020-03-31

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• 06971679949843 - Confocal Microprobe Imaging System: 2025-08-22
• 06971679949850 - Confocal Microprobe Imaging System: 2025-08-22