# K182376: Harmony

- Pathway: 510(k) (Special)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Sep 28, 2018 after 28 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: 10 generations back to K896095 (1990). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151952: Synergy ODM, Topcon Medical Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K232555: Harmony (2023), 1 descendant of its own
- K210396: Harmony Referral System (2021), 1 descendant of its own
- K260694: Zeiss Clinic 360 (2026), 0 descendants of its own
- K253893: Harmony Referral System with Harmony OCT Viewer (Octave) (2026), 0 descendants of its own

## Indications for use
Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Source page: https://510kreport.com/device/K182376
Methodology: https://510kreport.com/methodology