iConnect Access

GUDID 00842000100683

Stand alone software application.

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID00842000100683
NIH Device Record Keydc729b74-71f2-43c7-83df-c17c8adcd182
Commercial Distribution StatusIn Commercial Distribution
Brand NameiConnect Access
Version Model Number6.5
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842000100683 [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 Date2019-05-20
Device Publish Date2019-05-10

Devices Manufactured by MERGE HEALTHCARE SOLUTIONS INC.

00842000101123 - Merge Cardio2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste
00842000101147 - Merge PACS2023-12-06
00842000101086 - Merge PACS2023-09-22
00842000101130 - Merge Universal Viewer2023-09-07
00842000100904 - Merge OrthoTemplates2023-06-19 Software implant template
00842000101093 - Merge Universal Viewer2023-03-27
00842000101116 - CADstream2023-03-15 Standalone software application
00842000100003 - CADstream2021-09-29 Standalone Software Application

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