# K260694: Zeiss Clinic 360

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jul 17, 2026 after 136 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232555: Harmony, Topcon Healthcare Solutions (2023) Summary page 5.

## Indications for use
ZEISS CLINIC 360 is comprehensive software intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management and display of patient data, diagnostic data, clinical information, and reports from ophthalmic diagnostic instruments through computerized networks. The device aids in the detection, monitoring and management of various ocular diseases.

Source page: https://510kreport.com/device/K260694
Methodology: https://510kreport.com/methodology