iRay(k Taicang)

GUDID 06972093830144

Mars1417V-TSI Wireless Digital Flat Panel Detector k201004 Taicang

iRay Technology Taicang 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 Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID06972093830144
NIH Device Record Key6c9453c9-69e9-4ea2-a426-3ccf788d37ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameiRay(k Taicang)
Version Model NumberMars1417V-TSI
Company DUNS543860743
Company NameiRay Technology Taicang 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
GS106972093830144 [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 Date2020-05-25
Device Publish Date2020-05-15

On-Brand Devices [iRay(k Taicang) ]

06972093830144Mars1417V-TSI Wireless Digital Flat Panel Detector k201004 Taicang
06972093830168Mars1717V-VSI Wireless Digital Flat Panel Detector k201043 Taicang

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.