DIAGNOSTIC ULTRASOUND SYSTEM

GUDID 04987670102516

DIAGNOSTIC ULTRASOUND SYSTEM

CANON MEDICAL SYSTEMS CORPORATION

General-purpose ultrasound imaging system

• Primary Device ID: 04987670102516
• NIH Device Record Key: da178824-1a78-4944-8dc8-6690b10f04b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAGNOSTIC ULTRASOUND SYSTEM
• Version Model Number: TUS-AI800
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-8004211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670102516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161843

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: 2017-03-08

On-Brand Devices [DIAGNOSTIC ULTRASOUND SYSTEM]

• 04987670103469: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670103452: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670103353: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670103346: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670102981: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670102523: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670102516: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670102509: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100765: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100758: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100741: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100734: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100727: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100710: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670100703: DIAGNOSTIC ULTRASOUND SYSTEM
• 04987670103780: CUS-AA000
• 04987670104558: CUS-AGG00
• 04987670104541: CUS-AFL00