FDA.reportPublic FDA data

RadiForce®

Primary DI
14995047061110
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
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
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 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
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25