Client Outlook Inc

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

eUnity - 00628914000017 Catalog Number :

Device Description : eUnity software is a diagnostic medical imaging display workstation. As part of 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 Class : 2

Duns Number: 248599750

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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