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510(k) Data Aggregation
K Number
K130453Device Name
EXCELSIOR
Manufacturer
EYEKOR, LLC.
Date Cleared
2013-04-02
(39 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EYEKOR, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXCELSIOR Software is intended for use in importing, processing, measurement, analysis and storage of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials.
Device Description
The EXCELSIOR software is a cloud-based software that provides a grading platform integrating remote data collection, quantitative analysis and measurement, storage and management of ophthalmic data and images for clinical trials.
EXCELSIOR provides secure access through user authentication and role authorization, and is adherent to HIPAA and CFR 21 part 11 requirements for clinical investigations. EXCELSIOR user accounts can only be initiated by EXCELSIOR administrators or project managers: administrators or project managers enter in user information, and the user is prompted by email to setup his own user name and password. Once setup, the user access is defined by its role associated with a particular trial. EXCELSIOR provides 128-bit secure network encryption and audit trail logging to ensure that changes to the data are retraceable and re-constructible.
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