VIVIX-S 4386W

GUDID 08809394330616

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 08809394330616
• NIH Device Record Key: 0670832e-5437-46c3-8541-22c86295180e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVIX-S 4386W
• Version Model Number: FXRD-4386WB
• 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	08809394330616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220239

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

Devices Manufactured by VIEWORKS CO., LTD.

• 08809394330586 - VIVIX-S FW: 2023-10-23
• 08809394330593 - VIVIX-S FW: 2023-10-23
• 08809394330609 - VIVIX-S FW: 2023-10-23
• 08809394330616 - VIVIX-S 4386W: 2023-10-23
• 08809394330616 - VIVIX-S 4386W: 2023-10-23
• 08809394330296 - VIVIX-S 2530VAW: 2020-10-14 Flat Panel Detector of 25 cm by 30 cm size. Wireless
• 08809394330302 - VIVIX-S 2530VAW PLUS: 2020-10-14 Flat Panel Detector, wireless 25cm by 30 cm of size
• 08809394330319 - VIVIX-S 3643VAW: 2020-10-14 Flat Panel Detector, wireless 36cm by 43 cm of size
• 08809394330326 - VIVIX-S 3643VAW PLUS: 2020-10-14 Flat Panel Detector, wireless 36cm by 43 cm of size