VIVIX-S 1012N

GUDID 08809394330265

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector

• Primary Device ID: 08809394330265
• NIH Device Record Key: 111eac07-7ca9-4a43-a06f-a1757106b346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVIX-S 1012N
• Version Model Number: FXRD-1012NA
• 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	08809394330265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152855

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: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [VIVIX-S 1012N]

• 08809394330272: FXRD-1012NB
• 08809394330265: FXRD-1012NA