SonoMax Series Digital Color Doppler Ultrasound System

GUDID 06945121414814

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121414814
• NIH Device Record Key: e09201d1-9f90-4c8f-8c28-cb3b15366e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoMax Series Digital Color Doppler Ultrasound System
• Version Model Number: SonoMax 9
• 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	06945121414814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233697

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: 2024-08-23
• Device Publish Date: 2024-08-15

On-Brand Devices [SonoMax Series Digital Color Doppler Ultrasound System]

• 06945121415200: SonoMax 7
• 06945121414814: SonoMax 9