Wireless Digital Flat Panel Detector

GUDID 06970569090207

iRay Technology Co. Ltd.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID06970569090207
NIH Device Record Keyf2bb64d6-620c-4560-aa1e-3871b2de43da
Commercial Distribution StatusIn Commercial Distribution
Brand NameWireless Digital Flat Panel Detector
Version Model NumberMars1417X
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970569090207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [Wireless Digital Flat Panel Detector]

06970569090160Mars1417V-PSI wireless digital flat panel detector with only one package and with E-COM software
06970569090153Mars1417V-TSI(Configuration: Mars1417VT-TSI) wireless flat panel detector with only one package.
06970569090146Mars1417V-PSI wireless digital flat panel detector with only one package.
06970569090115Mars1417V-TSI
06970569090108Mars1417V-PSI
06972093830052Mars1012V
06970569090214Mars1717X
06970569090207Mars1417X

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