Change Healthcare Stratus Imaging PACS

GUDID 17540262160147

Change Healthcare Canada Company

Radiological PACS software
Primary Device ID17540262160147
NIH Device Record Key33c67ca1-0270-43e7-87a0-a8868d12336d
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Stratus Imaging PACS
Version Model Number1.4.6
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
GS117540262160147 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

On-Brand Devices [Change Healthcare Stratus Imaging PACS]

175402621600170.6.0
175402621600240.7.0
175402621600311.0.0
175402621600551.0.1
175402621600481.1.0
175402621600621.1.1
175402621600791.2.0
175402621600861.3.0
175402621600931.4.0
175402621601091.4.1
175402621601161.4.3
175402621601301.4.5
175402621601471.4.6

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