FDA.reportPublic FDA data

MX50N

Primary DI
08809241513186
Brand
MX50N
Company
WIDE corporation
Model
MX50N
Device description
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
Published
2026-07-16
Public version status
New
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
K170781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170781000MX50N(MX50YQS)Wide Corporation2017-04-04PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809241513186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809241513186088092415131868809241513186

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.

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
08809241513001MX50TMX50TQS2016-09-21
08809241513018MX50NMX50YQS2016-09-21
08809241513025MX30NMX30TQS2016-09-21
08809241513032CX50NCX50YQS2016-09-21
08809241513049CX30NCX30PQX2016-09-21
08809241513056CX20NCX20PUX2016-09-21
08809241513070CX50NCX50YQS2017-04-27
08809241513087MX50NMX50YQS2017-04-27
08809241513124CW120NCW120N2021-04-20
08809241513131CX30NCX30PQX2021-04-26
088092415130636MPCW602016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809241513148CW60NWIDE corporationPGY2026-07-16
08809241513155CL24NWIDE corporationPGY2026-07-16
08809241513179CX50NWIDE corporationPGY2026-07-16
05415334061750BarcoBarco NVPGY2026-06-02
06970027821411BeaconShenzhen Beacon Display Technology Co., Ltd.PGY2026-05-27
05415334057265Nio Color 8MPBarco NVPGY2026-05-07
04719875210211DIVADIVA LABORATORIES, LTD.PGY2026-04-21
04719875210525DIVADIVA LABORATORIES, LTD.PGY2026-04-21
05415334060159Nio 5.8MP GrayBarco NVPGY2025-12-01
08806096660263LGLG Electronics Inc.PGY2025-09-19
04995047070542RadiForce®EIZO CORPORATIONPGY2025-09-12
04995047060727RadiForce®EIZO CORPORATIONPGY2025-09-08
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
04995047068259RadiForce®EIZO CORPORATIONPGY2025-07-11
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