eFilm Workstation

GUDID 00842000100287

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software
Primary Device ID00842000100287
NIH Device Record Keye755a1a4-5a66-42b1-9bd3-1e25a5a76be9
Commercial Distribution StatusIn Commercial Distribution
Brand NameeFilm Workstation
Version Model Number4.2
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
GS100842000100287 [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 Date2016-12-01

On-Brand Devices [eFilm Workstation]

008420001006524.2.1
00842000100287Standalone software application
00842000100850Standalone software application

Trademark Results [eFilm Workstation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EFILM WORKSTATION
EFILM WORKSTATION
77335593 3563272 Live/Registered
Merge Healthcare Incorporated
2007-11-21

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