# K232088: Altris IMS

- Pathway: 510(k) (Traditional)
- Applicant: Altris, Inc.
- Decided: Jul 31, 2023 after 18 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K896095 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211715: RetinAI Discovery, Retinai Medical AG (2022) Summary page 4.

## Indications for use
The Altris IMS 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, 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.

Source page: https://510kreport.com/device/K232088
Methodology: https://510kreport.com/methodology