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510(k) Data Aggregation
K Number
K110869Device Name
CARA
Manufacturer
Date Cleared
2011-07-14
(107 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundus images as well as visualization of original and enhanced image through computerized networks.
Device Description
CARA is a software platform that collects, enhances, stores, and manages color fundus images. Through the internet, CARA software collects and manages color fundus images from a range of approved computerized digital imaging devices. CARA enables a real-time review of retinal image data (both original and enhanced) from an internet-browser-based user interface to allow authorized users to access and view data saved in a centralized database. The system utilizes state-of-the-art encryption tools to ensure a secure networking environment.
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