FDA.report

RadiForce®

Primary DI
04995047064824
Brand
RadiForce®
Company
EIZO CORPORATION
Model
MX317W
Catalog number
MX317W-BK
Device description
8MP Color LCD Monitor
Published
2023-12-29
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
PGYDisplay, Diagnostic Radiology

Product Code Classifications

CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions

SubmissionSupplement
K233465000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233465000RadiForce MX317WEizo Corporation2023-12-21PGY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04995047064824PrimaryGS10

GMDN Terms

TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will 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

Contacts

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 DIBrandModelCatalogPublished
04995047070542RadiForce®MX243WMX243W-GHBK2025-09-12
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-AE2025-07-18
04995047070320CuratOREX3220EX3220-WT2025-07-18
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
14995047068041RadiForce®RX570RX570-BK-MD2024-12-05
04995047068167RadiForce®RX570RX570-ARBK2024-12-05
04995047068242RadiForce®RX570RX570-BK2024-12-05
14995047068348RadiForce®RX570RX570-ARBK-MD2024-12-05
04995047067740RadiCSVer.5.2.xRadiCS2024-11-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05415334060159Nio 5.8MP GrayBarco NVPGY2025-12-01
08806096660263LGLG Electronics Inc.PGY2025-09-19
04995047070542RadiForce®EIZO CORPORATIONPGY2025-09-12
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
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
14995047068041RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068167RadiForce®EIZO CORPORATIONPGY2024-12-05
04995047068242RadiForce®EIZO CORPORATIONPGY2024-12-05
14995047068348RadiForce®EIZO CORPORATIONPGY2024-12-05
05415334050358Nio Color 2MPBarco NVPGY2024-11-27
05415334050365Nio Color 2MPBarco NVPGY2024-11-27
05415334050372Nio Color 3MPBarco NVPGY2024-11-27
05415334050389Nio Color 3MPBarco NVPGY2024-11-27