iRay(k)

Basic Information

• Brand Name: iRay(k)
• Primary DI: 06972093830106
• Version / Model: Mars1417V-TSI
• Company Name: iRay Technology Taicang Ltd.
• Labeler DUNS: 543860743
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-09
• Public Version: 2
• Public Version Date: 2020-06-02
• Public Version Status: Update
• Public Device Record Key: f7a1b0f5-d90d-4d01-a52c-aecbf9d00930

Device Description

Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61108	Indirect flat panel x-ray detector	An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972093830106	GS1