ViVIX-S with VXvue

GUDID 08809394330005

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector

• Primary Device ID: 08809394330005
• NIH Device Record Key: cbe3e3b1-b665-4efc-ab3c-62bbbb96477f
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViVIX-S with VXvue
• Version Model Number: FXRD-1717SA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809394330005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122866

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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-07-08

On-Brand Devices [ViVIX-S with VXvue]

• 08809394330081: FXRD-1417SB
• 08809394330050: FXRD-1417SA
• 08809394330005: FXRD-1717SA