IBM iConnect Access 8.1

GUDID 00842000100980

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation
Primary Device ID00842000100980
NIH Device Record Key5ecb59b8-95a7-466c-a344-c1ef6dc420ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBM iConnect Access 8.1
Version Model Number8.1
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
GS100842000100980 [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 Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by MERGE HEALTHCARE SOLUTIONS INC.

00842000100980 - IBM iConnect Access 8.12021-05-03
00842000100980 - IBM iConnect Access 8.12021-05-03
00842000100850 - eFilm Workstation2021-02-16 Standalone software application
00842000100867 - eFilm Lite2021-02-16 Standalone software application
00842000100881 - CADstream2021-02-16 Standalone Software Application
00842000100874 - Merge Hemo 2020-05-01
00842000100843 - IBM iConnect Access 2020-04-10
00842000100768 - Merge Cardio 2020-02-10
00842000100805 - Merge PACS2019-12-05

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