Wireless Digital Flat Panel Detector(19 pin)

GUDID 06970569090887

Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

iRay Technology Co. Ltd.

Indirect flat panel x-ray detector

• Primary Device ID: 06970569090887
• NIH Device Record Key: 0c54e06e-2a0d-4f17-8d21-4b8fd202965d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wireless Digital Flat Panel Detector(19 pin)
• Version Model Number: Mars1417X
• Company DUNS: 421363780
• Company Name: iRay Technology 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: true
• 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	06970569090887 [Primary]

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: 2024-10-24
• Device Publish Date: 2024-10-16

On-Brand Devices [Wireless Digital Flat Panel Detector(19 pin)]

• 06970569090887: Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solution
• 06970569090870: Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutio