IBM iConnect Access

GUDID 90842000100914

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID90842000100914
NIH Device Record Keyaf929863-199a-4f70-8099-fc9998887ff2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBM iConnect Access
Version Model Number8.0
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
GS190842000100914 [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 Date2021-09-29
Device Publish Date2021-09-21

On-Brand Devices [IBM iConnect Access]

008420001007207.0
008420001007827.1
008420001008437.2
908420001009148.0
008420001010249.0
008420001010178.2

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