FXRD-1012N

GUDID 08809394330166

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector

• Primary Device ID: 08809394330166
• NIH Device Record Key: 52dd3380-159e-4b09-8828-a093ce44ff78
• Commercial Distribution Discontinuation: 2020-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FXRD-1012N
• Version Model Number: FXRD-1012NAW
• 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	08809394330166 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-07-15

On-Brand Devices [FXRD-1012N]

• 08809394330173: FXRD-1012NBW
• 08809394330166: FXRD-1012NAW