iRay

Basic Information

• Brand Name: iRay
• Primary DI: 06975501940282
• Version / Model: CRUX RF10
• Company Name: iRay Imaging Technology (Haining) Limited
• Labeler DUNS: 722762367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-20
• Public Version: 1
• Public Version Date: 2024-07-29
• Public Version Status: New
• Public Device Record Key: 81ec4bcc-12b8-4885-a399-8b4e87c9f4d6

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZW	Collimator, Automatic, Radiographic	Radiology	892.1610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33136	Automatic-aperture-control diagnostic x-ray system collimator	A standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It typically includes a light-centring device that is used to project a light field onto the patient that is coincident with the x-ray beam in order to centre the tube over the film cassette. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975501940282	GS1