FDXConsole

GUDID 04547410316865

The Console Advance is a workstation intended to associate digital (for CR and/or DR) images. with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

FUJIFILM CORPORATION

Computed radiography digital imaging scanner

• Primary Device ID: 04547410316865
• NIH Device Record Key: 2c27da27-9876-4967-8ef0-37b5660fbd84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDXConsole
• Version Model Number: DR-ID300CL
• Company DUNS: 713565195
• Company Name: FUJIFILM 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: true
• Serial Number: false
• 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: +018002728465
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410316865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041990

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-16

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