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Cw120n

FDA UDI

Class II (US FDA UDI)

by Wide Corporation

Identity

Trade Name
CW120N FDA UDI
Generic Name
Image display unit, colour FDA UDI
Device Name
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. FDA UDI
Model / Reference
CW120N FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08809241513124 FDA UDI
510(k) Number
K210491 FDA UDI
FDA Product Code
PGY FDA UDI
GMDN Term
Image display unit, colour FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Image display unit, colour

Cw120n by Wide Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Image display unit, colour.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wide Corporation

Sources (1)

  • FDA UDI 2b7dd737-774f-4d67-9b02-656e7443edfe 34 fields · synced May 30, 2026