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510(k) Data Aggregation
K Number
K232088Device Name
Altris IMS
Manufacturer
Altris, Inc.
Date Cleared
2023-07-31
(18 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Altris, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
Device Description
Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files. Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis. The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms. The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).
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