CADstream

GUDID 00842000100881

Standalone Software Application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID00842000100881
NIH Device Record Key43deb42b-6e9c-4b5b-9fd1-e84b15051881
Commercial Distribution StatusIn Commercial Distribution
Brand NameCADstream
Version Model Number6.3
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
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 Datetrue
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
GS100842000100881 [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 Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [CADstream]

00842000100638Standalone Software Application
00842000100881Standalone Software Application
00842000101031Standalone Software Application
00842000100003Standalone Software Application
00842000101116Standalone software application

Trademark Results [CADstream]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CADSTREAM
CADSTREAM
78249707 2838749 Live/Registered
MERGE HEALTHCARE SOLUTIONS INC.
2003-05-14

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