CX30N - The CX30N(CX30PQX) LCD Monitor System is intended - WIDE corporation

Duns Number:688285899

Device Description: The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing dig The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

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More Product Details

Catalog Number

-

Brand Name

CX30N

Version/Model Number

CX30PQX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210493

Product Code Details

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Device Record Status

Public Device Record Key

71413ebc-f394-49de-8657-a5d31ae58aa4

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WIDE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11