FDA.reportPublic FDA data

RadiForce®

Primary DI
14995047060724
Brand
RadiForce®
Company
EIZO CORPORATION
Model
GX570
Catalog number
GX570-ARBK-MD
Device description
5MP Monochrome LCD Monitor
Published
2025-09-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGYDisplay, Diagnostic Radiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252030000RadiForce GX570; RadiForce GX570-AREizo Corporation2025-08-28PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14995047060724PackageGS12In Commercial Distribution
04995047060727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1499504706072414995047060724
04995047060727049950470607274995047060727

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, monochromeAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in only one colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-900-8383support@eizo.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04995047074816CuratORMIR-1MIR-12026-05-29
04995047074946CuratOREX3242-3DEX3242-3D-NLWT2026-05-29
04995047070542RadiForce®MX243WMX243W-GHBK2025-09-12
04995047060727RadiForce®GX570GX570-ARBK-MD2025-09-08
04995047060567RadiForce®GX570GX570-BK2025-09-08
04995047060611RadiForce®GX570GX570-BK-MD2025-09-08
04995047060666RadiForce®GX570GX570-ARBK2025-09-08
04995047060758RadiForce®GX570GX570-BK-P2025-09-08
04995047069867CuratOREX3242-3D, PR050EX3242-3D-AEWT2025-07-18
04995047070320CuratOREX3220EX3220-WT2025-07-18
04995047068259RadiForce®RX570RX570-BK-MD2025-07-11
04995047052814RadiForce®MX194MX194-SIBK2025-07-11
04995047064404RadiForce®RX370RX370-SIBK2025-07-11
04995047065661RadiForce®MX243WMX243W-SIBK2025-07-11
04995047067849RadiForce®MX217MX217-SIBK2025-07-11
14995047068256RadiForce®RX570RX570-BK-MD2025-07-11
04995047069959CuratOREX3220-3DEX3220-3D-WT2025-05-01
04995047069997NAEX3220-3D, PV648EX3220-3D-AE2025-04-25
04995047053217RadiForce®GX560GX560-BK-MD2018-09-04
04995047068044RadiForce®RX570RX570-BK-MD2024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334061750BarcoBarco NVPGY2026-06-02
06970027821411BeaconShenzhen Beacon Display Technology Co., Ltd.PGY2026-05-27
05415334057265Nio Color 8MPBarco NVPGY2026-05-07
04719875210211DIVADIVA LABORATORIES, LTD.PGY2026-04-21
04719875210525DIVADIVA LABORATORIES, LTD.PGY2026-04-21
05415334060159Nio 5.8MP GrayBarco NVPGY2025-12-01
08806096660263LGLG Electronics Inc.PGY2025-09-19
04995047070542RadiForce®EIZO CORPORATIONPGY2025-09-12
04995047060727RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060567RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060611RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060666RadiForce®EIZO CORPORATIONPGY2025-09-08
04995047060758RadiForce®EIZO CORPORATIONPGY2025-09-08
05415334054967Nio 5.8MP ColorBarco NVPGY2025-08-11
05415334054974Nio 5.8MP ColorBarco NVPGY2025-08-11
05415334054981Nio 5.8MP GrayBarco NVPGY2025-08-11
05415334054998Nio 5.8MP GrayBarco NVPGY2025-08-11
05415334058415BarcoBarco NVPGY2025-08-05
04995047068259RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047052814RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047064404RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047065661RadiForce®EIZO CORPORATIONPGY2025-07-11
04995047067849RadiForce®EIZO CORPORATIONPGY2025-07-11
14995047068256RadiForce®EIZO CORPORATIONPGY2025-07-11
05415334049895Coronis Fusion 4MPBarco NVPGY2025-04-16
05415334049901Coronis Fusion 4MPBarco NVPGY2025-04-16
05415334049925Coronis Fusion 6MPBarco NVPGY2025-04-16
05415334049932Coronis Fusion 6MPBarco NVPGY2025-04-16
04995047068044RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068341RadiForce®EIZO CORPORATIONPGY2024-12-05