FDA.reportPublic FDA data

RadiForce®

Primary DI
14995047061219
Brand
RadiForce®
Company
EIZO CORPORATION
Model
GX240
Catalog number
GX240-CL-BK-P
Device description
2MP 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
K120407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1204070002MP MONOCHROME LCD MONITOR, RADIFORCE GX240Eizo Nanao Corporation2012-04-19LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14995047061219PackageGS12In Commercial Distribution
04995047040217PreviousGS10
04995047061212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1499504706121914995047061219
04995047040217049950470402174995047040217
04995047061212049950470612124995047061212

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
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05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20