eUnity

Basic Information

• Brand Name: eUnity
• Primary DI: 00628914000017
• Version / Model: eUnity-1
• Company Name: Client Outlook Inc
• Labeler DUNS: 248599750
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-28
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: f57b5c4f-6143-4352-978a-e0d92ee962a9

Device Description

eUnity software is a diagnostic medical imaging display workstation. As part of an EMR, Portal or as a stand-alone application, eUnity provides secure access to full-fidelity DICOM images with unprecedented performance using nothing more than a common web-browser (no client software to manage.) Medical professionals can now access medical images across multiple sites and multiple PACS using eUnity as their image viewing platform.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628914000017	GS1