Xplorer 1800 Digital Radiographic System

GUDID 00823073061019

Digital Radiographic System

Imaging Dynamics Company Ltd

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital
Primary Device ID00823073061019
NIH Device Record Key87a424c2-4a6b-4c4c-9752-ffd850b0032f
Commercial Distribution StatusIn Commercial Distribution
Brand NameXplorer 1800 Digital Radiographic System
Version Model Number1800 X4C
Company DUNS252909973
Company NameImaging Dynamics Company 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(403)251-9939
Emailinfo@imagingdynamics.com
Phone+1(403)251-9939
Emailinfo@imagingdynamics.com

Device Dimensions

Weight875 Kilogram
Weight875 Kilogram
Weight875 Kilogram
Weight875 Kilogram
Weight875 Kilogram
Weight875 Kilogram

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100823073061019 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-26

Devices Manufactured by Imaging Dynamics Company Ltd

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00823073003217 - Aquarius 86002019-02-21 Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
00823073005112 - Aquarius 86002019-02-21 Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
00823073005211 - Aquarius 86002019-02-21 Flat Panel Digital Medical X-Ray Detector.
00823073001015 - Xplorer 1000 Detector Head (X4C)2018-03-29 CCD Detector
00823073001022 - X3C Detector Head2018-03-29 CCD Detector
00823073001039 - Xaminer Detector Head2018-03-29 CCD Detector

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