CX30N

GUDID 08809241513131

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.

WIDE corporation

Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour
Primary Device ID08809241513131
NIH Device Record Key71413ebc-f394-49de-8657-a5d31ae58aa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCX30N
Version Model NumberCX30PQX
Company DUNS688285899
Company NameWIDE corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809241513131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGYDisplay, Diagnostic Radiology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.