Wireless Digital Flat Panel Detector(19 pin)

GUDID 06970569090870

Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

iRay Technology Co. Ltd.

Indirect flat panel x-ray detector
Primary Device ID06970569090870
NIH Device Record Key39f20380-f46f-4254-9603-2eefd03faac4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWireless Digital Flat Panel Detector(19 pin)
Version Model NumberMars1717X
Company DUNS421363780
Company NameiRay Technology Co. Ltd.
Device Count1
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970569090870 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-24
Device Publish Date2024-10-16

On-Brand Devices [Wireless Digital Flat Panel Detector(19 pin)]

06970569090887Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solution
06970569090870Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutio

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