QBit Series Diagnostic Ultrasound System

GUDID 06945121414715

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06945121414715
• NIH Device Record Key: a353c3aa-d0bd-4323-a2dd-b2741f5a8976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QBit Series Diagnostic Ultrasound System
• Version Model Number: QBit 3
• 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	06945121414715 [Primary]
GS1	06945121414722 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	06945121414739 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	06945121414746 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	06945121414753 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150861

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2023-04-19
• Device Publish Date: 2023-04-11

On-Brand Devices [QBit Series Diagnostic Ultrasound System]

• 06945121403269: QBit 9
• 06945121403245: QBit 7
• 06945121403221: QBit 5
• 06945121414715: QBit 3