VIVIX-S FW

GUDID 08809394330609

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector

• Primary Device ID: 08809394330609
• NIH Device Record Key: 65d81586-242c-471b-a341-b33d47a00141
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVIX-S FW
• Version Model Number: FXRD-4343FAW
• Company DUNS: 688274778
• Company Name: VIEWORKS 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809394330609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221512

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-13

On-Brand Devices [VIVIX-S FW]

• 08809394330609: FXRD-4343FAW
• 08809394330593: FXRD-3643FAW
• 08809394330586: FXRD-2530FAW