RadiForce®

Basic Information

• Brand Name: RadiForce®
• Primary DI: 04995047040217
• Version / Model: GX240
• Catalog Number: GX240-CL-BK-P
• Company Name: EIZO CORPORATION
• Labeler DUNS: 691033005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: e848f496-e5de-409d-a183-65e3a9f5401d

Device Description

2MP Monochrome LCD Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36615	Image display unit, monochrome	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in only one text/image colour, e.g., measured values or images from other devices. The information displayed will be limited (the view will become confusing to the user when too much information is shown). A keyboard may be connected for interactive manipulation of the data by the user. This group of devices is the product identifier for the monitor only and does not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14995047040214	GS1	Box	2	In Commercial Distribution
Primary	04995047040217	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120407	000