INTERVENTIONAL ANGIOGRAPHY SYSTEM

GUDID 04987670100215

INTERVENTIONAL ANGIOGRAPHY SYSTEM

CANON MEDICAL SYSTEMS CORPORATION

Stationary angiographic x-ray system, digital

• Primary Device ID: 04987670100215
• NIH Device Record Key: f259946f-4691-4574-b8c7-6e03b57feefd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERVENTIONAL ANGIOGRAPHY SYSTEM
• Version Model Number: INFX-8000H
• 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	04987670100215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082830

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [INTERVENTIONAL ANGIOGRAPHY SYSTEM]

• 04987670100222: INTERVENTIONAL ANGIOGRAPHY SYSTEM
• 04987670100215: INTERVENTIONAL ANGIOGRAPHY SYSTEM
• 04987670100208: INTERVENTIONAL ANGIOGRAPHY SYSTEM
• 04987670100192: INTERVENTIONAL ANGIOGRAPHY SYSTEM