P10xp/8-4 MHz P17780

GUDID 00841517111793

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517111793
• NIH Device Record Key: d287b710-10a7-4681-a8d0-3fdf2bc031d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P10xp/8-4 MHz
• Version Model Number: P17780-21A
• Catalog Number: P17780
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, INC.
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 KiloPascal and 95 KiloPascal
• Handling Environment Temperature: Between -35 KiloPascal and 60 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 KiloPascal and 95 KiloPascal
• Storage Environment Temperature: Between -35 KiloPascal and 60 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517111793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171437

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [P10xp/8-4 MHz]

• 00841517101244: Diagnostic Ultrasound Transducer
• 00841517101121: Diagnostic Ultrasound Transducer
• 00841517107109: Diagnostic Ultrasound Transducer
• 00841517109509: Diagnostic Ultrasound Transducer
• 00841517111793: Diagnostic Ultrasound Transducer