McKesson Radiology

GUDID 17540262020021

Change Healthcare Canada Company

Radiology picture archiving and communication system application software
Primary Device ID17540262020021
NIH Device Record Key43745f3f-0d2a-4dc6-832f-e98a959b947d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMcKesson Radiology
Version Model Number12.4
Company DUNS246576391
Company NameChange Healthcare Canada Company
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117540262020021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-09-24
Device Publish Date2018-06-11

Devices Manufactured by Change Healthcare Canada Company

17540262130195 - Change Healthcare Stratus Imaging Viewer2024-08-29
17540262160147 - Change Healthcare Stratus Imaging PACS2024-07-08
17540262130188 - Change Healthcare Stratus Imaging Viewer2024-06-26
17540262160130 - Change Healthcare Stratus Imaging PACS2024-06-21
17540262160116 - Change Healthcare Stratus Imaging PACS2024-05-13
17540262160109 - Change Healthcare Stratus Imaging PACS2024-05-07
17540262090130 - Change Healthcare Cardiology2024-02-16
17540262100129 - Change Healthcare Cardiology Hemo2024-02-16

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