RadiCS

Basic Information

• Brand Name: RadiCS
• Primary DI: 04995047067740
• Version / Model: Ver.5.2.x
• Catalog Number: RadiCS
• Company Name: EIZO CORPORATION
• Labeler DUNS: 691033005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-08
• Public Version: 1
• Public Version Date: 2024-11-18
• Public Version Status: New
• Public Device Record Key: 809bd041-1c17-43fd-b41e-a6f747661039

Device Description

Quality Control Software

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	892.1940	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64325	Radiology workstation display quality assurance software	A software application intended to be used to measure, calibrate, and adjust the display parameters of a radiology workstation monitor to standardize the quality level of digital radiological images (DICOM images) displayed by the monitor. It is typically used to manage the display quality of several computers within a healthcare facility, and to feed data (e.g., alerts) back to a central user(s). It is not intended for image processing, distribution, or viewing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04995047067740	GS1

Customer Contacts

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