iRay

GUDID 06972093830045

Mars1717XF-CSI Wireless Digital Flat Panel Detector

iRay Technology Taicang Ltd.

Indirect flat panel x-ray detector

• Primary Device ID: 06972093830045
• NIH Device Record Key: 0694a31e-1b55-46ca-9eed-9be707197e5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRay
• Version Model Number: Mars1717XF-CSI
• Company DUNS: 543860743
• Company Name: iRay Technology Taicang 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: true
• 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	06972093830045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183713

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: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [iRay]

• 06972093830038: Mars1717XF-GSI Wireless Digital Flat Panel Detector
• 06972093830021: Mars1417XF-CSI Wireless Digital Flat Panel Detector
• 06972093830014: Mars1417XF-GSI Wireless Digital Flat Panel Detector
• 06972093830045: Mars1717XF-CSI Wireless Digital Flat Panel Detector
• 06972093830083: Mars1717V-VSI Wireless Digital Flat Panel Detector
• 06972093830069: Mars1417V-TSI Wireless Digital Flat Panel Detector