Change Healthcare Enterprise Viewer

GUDID 17540262010039

Change Healthcare Canada Company

Radiology PACS software Radiology PACS software Radiology PACS software
Primary Device ID17540262010039
NIH Device Record Key73f91f0d-7313-4713-b683-2579ef65b8fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Enterprise Viewer
Version Model Number2.1
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
GS117540262010039 [Primary]
GS117540262010039 [Primary]
GS117540262010039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
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 Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Change Healthcare Enterprise Viewer]

175402620100222.0
175402620100392.1

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.