Change Healthcare Anatomical AI™

GUDID 17540262150018

Change Healthcare Canada Company

Radiology PACS software
Primary Device ID17540262150018
NIH Device Record Key2853dd0c-ae1c-4ece-b5c7-6ae1836dddf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Anatomical AI™
Version Model Number1.0.0
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
GS117540262150018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

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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