# K234076: iCare ALTIUS CW

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Aug 22, 2024 after 245 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: 9 generations back to K896095 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213527: FORUM, Carl Zeiss Meditec, AG (2022) Summary page 8.

## Indications for use
iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.

Source page: https://510kreport.com/device/K234076
Methodology: https://510kreport.com/methodology