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510(k) Data Aggregation
K Number
K211715Device Name
RetinAI Discovery
Manufacturer
RetinAI Medical AG
Date Cleared
2022-04-28
(329 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RetinAI Medical AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
Device Description
The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.
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