FDA.reportPublic FDA data

RadiForce®

Primary DI
04995047048282
Brand
RadiForce®
Company
EIZO CORPORATION
Model
GX550
Catalog number
GX550-ARBK
Device description
5MP Monochrome LCD Monitor
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K162497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1624970005MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation2016-09-19PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04995047048282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04995047048282049950470482824995047048282

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, monochromeA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used 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 GMDN code 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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
691033005
Device count
1
Serial number
true
Manufacturing date on label
true

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
14995047060724RadiForce®GX570GX570-ARBK-MD2025-09-08
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

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
14995047060724RadiForce®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