Merge iConnect Access

GUDID 00842000100126

Standalone software application.

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software
Primary Device ID00842000100126
NIH Device Record Key84ab2621-be8f-4ea5-a342-5620263822bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge iConnect Access
Version Model Number6.3
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100842000100126 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-23
Device Publish Date2016-12-12

On-Brand Devices [Merge iConnect Access]

00842000100645Software application that provides internet access to multi-modality softcopy medical images, re
00842000100126Standalone software application.

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