SonoBook Series Diagnostic Ultrasound Systems

GUDID 06945121414166

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121414166
• NIH Device Record Key: 0093e3c2-2b2b-4588-8250-6dc1f6b27910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoBook Series Diagnostic Ultrasound Systems
• Version Model Number: SonoBook 5
• Company DUNS: 544914187
• Company Name: CHISON 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945121414159 [Primary]
GS1	06945121414166 [Package]; Contains: 06945121414159; Package: [1 Units]; In Commercial Distribution
GS1	06945121414173 [Package]; Contains: 06945121414159; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170374

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-21
• Device Publish Date: 2022-09-13

On-Brand Devices [SonoBook Series Diagnostic Ultrasound Systems]

• 06945121412681: SonoBook 8
• 06945121411172: SonoBook 9
• 06945121413305: SonoBook 7
• 06945121414166: SonoBook 5