FDA.report

RadiCS

Primary DI
04995047067740
Brand
RadiCS
Company
EIZO CORPORATION
Model
Ver.5.2.x
Catalog number
RadiCS
Device description
Quality Control Software
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04995047067740PrimaryGS10

GMDN Terms

TermDefinition
Radiology workstation display quality assurance softwareA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-900-8383support@eizo.com

Regulatory Flags

DUNS number
691033005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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