FDA.reportPublic FDA data

RadiForce®

Primary DI
04995047061113
Brand
RadiForce®
Company
EIZO CORPORATION
Model
GX340
Catalog number
GX340-CL-BK-P
Device description
3MP Monochrome LCD Monitor
Published
2021-07-30
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1137840003MP MONOCHROME LCD MONITOR, RADIFORCE GX340Eizo Nanao Corporation2012-03-02LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14995047061110PackageGS12In Commercial Distribution
04995047040255PreviousGS10
04995047061113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1499504706111014995047061110
04995047040255049950470402554995047040255
04995047061113049950470611134995047061113

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.

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
04995047072416CuratOREX2742EX2742-WT2026-09-25
04995047074816CuratORMIR-1MIR1USZZRW2026-05-29
04995047069485RadiCSVer.5.3RadiCS Ver.5.32026-09-04
04995047071655RadiCSVer.5.2RadiCS LE Ver.5.22026-09-04
04995047071662RadiCSVer.5.3RadiCS LE Ver.5.32026-09-04
04995047069300RadiForce®RX670ARX670A-ARBK2026-07-22
04995047069362RadiForce®RX670ARX670A-BK2026-07-22
04995047072676RadiForce®RX370ARX370A-SIBK2026-07-22
04995047072683RadiForce®RX370ARX370A-BK2026-07-22
04995047072843RadiForce®RX370ARX370A-ARBK2026-07-22
04995047072904RadiForce®MX217AMX217A-SIBK2026-07-22
04995047072935RadiForce®MX217AMX217A-BK2026-07-22
04995047072973RadiForce®RX570ARX570A-ARBK-MD2026-07-22
04995047073055RadiForce®RX570ARX570A-BK-MD2026-07-22
04995047073185RadiForce®RX570ARX570A-BK2026-07-22
04995047073208RadiForce®RX570ARX570A-BK-MD2026-07-22
04995047073277RadiForce®RX570ARX570A-ARBK2026-07-22
04995047073338RadiForce®MX243WAMX243WA-SIBK2026-07-22
04995047073376RadiForce®MX243WAMX243WA-GHBK2026-07-22
04995047073444RadiForce®MX243WAMX243WA-BK2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
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00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03