Genoray

Basic Information

• Brand Name: Genoray
• Primary DI: 08809244061172
• Version / Model: SUNI Pan Q-C
• Company Name: GENORAY CO., LTD.
• Labeler DUNS: 631064672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-28
• Public Version: 4
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 1f55c310-fbc4-4aa5-8957-efd924e10840

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43369	Stationary panoramic dental x-ray system, digital	A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809244061172	GS1

Premarket Submissions

Submission Number	Supplement Number
K141700	000