# K213527: FORUM

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Aug 15, 2022 after 284 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: 8 generations back to K896095 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match, Carl Zeiss Meditec, AG (2012) Summary page 4.

## Most influential descendants
- K234076: iCare ALTIUS CW (2024), 0 descendants of its own

## Indications for use
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace). FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

Source page: https://510kreport.com/device/K213527
Methodology: https://510kreport.com/methodology