CHISON iVis Series & Q Series,i3 Diagnostic Ultras

GUDID 06945121409445

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 06945121409445
• NIH Device Record Key: 8b4eb97f-0d2b-4df0-aa16-0584ecd48d20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHISON iVis Series & Q Series,i3 Diagnostic Ultras
• Version Model Number: i3
• 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	06945121409315 [Primary]
GS1	06945121409346 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409353 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409360 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409377 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409384 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409391 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409407 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409414 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409421 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409438 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution
GS1	06945121409445 [Package]; Contains: 06945121409315; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153085

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-10

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

• 06945121414524 - SonoAir Series Digital Color Doppler Ultrasound System: 2023-08-15
• 06945121414531 - Convex probe: 2023-08-15
• 06945121414548 - Linear probe: 2023-08-15
• 06945121414555 - Phased array probe: 2023-08-15
• 06945121414562 - Convex probe: 2023-08-15
• 06945121414579 - Micro convex probe: 2023-08-15
• 06945121414609 - SonoAir Series Digital Color Doppler Ultrasound System: 2023-08-15
• 06945121414777 - SonoAir Series Digital Color Doppler Ultrasound System: 2023-08-15