FDA.reportPublic FDA data

CW120N

Primary DI
08809241513124
Brand
CW120N
Company
WIDE corporation
Model
CW120N
Device description
CW120N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
Published
2021-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K210491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210491000CW120NWide Corporation2021-04-08PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809241513124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809241513124088092415131248809241513124

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn 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 colour. The device(s) that generates the visual data is not included with the display unit.

Regulatory Flags#

DUNS number
688285899
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
08809241513148CW60NCW60N2026-07-16
08809241513155CL24NCL24N2026-07-16
08809241513179CX50NCX50N2026-07-16
08809241513186MX50NMX50N2026-07-16
08809241513001MX50TMX50TQS2016-09-21
08809241513018MX50NMX50YQS2016-09-21
08809241513025MX30NMX30TQS2016-09-21
08809241513032CX50NCX50YQS2016-09-21
08809241513049CX30NCX30PQX2016-09-21
08809241513056CX20NCX20PUX2016-09-21
08809241513070CX50NCX50YQS2017-04-27
08809241513087MX50NMX50YQS2017-04-27
08809241513131CX30NCX30PQX2021-04-26
088092415130636MPCW602016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069300RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047069362RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072676RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072935RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073055RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073376RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073673RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073703RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073819RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073871RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073895RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074311RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074373RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074441RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074588RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074601RadiForce®EIZO CORPORATIONPGY2026-07-22
08809241513148CW60NWIDE corporationPGY2026-07-16
08809241513155CL24NWIDE corporationPGY2026-07-16